San Francisco AIDS Foundation
Open Clinical Trials

Winter 2005/2006


Below is a selected listing of currently enrolling clinical trials gathered from various sources. TrialSearch, operated by the AIDS Community Research Initiative of America (ACRIA), is an extensive online database of clinical trials related to HIV/AIDS. The University of California at San Francisco's HIV InSite Web site features TrialScope, a database of organizations that conduct HIV/AIDS-related research.

The federal government's AIDSinfo site includes a section on clinical trials that features an introduction to HIV/AIDS research and study listings from the National Institutes of Health's ClinicalTrials.gov database. AIDSinfo also offers personalized advice about clinical trial participation via e-mail (ContactUs@AIDSinfo.nih.gov), an interactive Web site (www.aidsinfo.nih.gov/live_help; specialists available Mon.-Fri. 9:00 am - 1:00 pm PT), and a toll-free telephone service (800-874-2572, international 301-874-2572; specialists available Mon.-Fri. 9:00 am - 2:00 pm PT). CenterWatch is a commercial Web site that includes trial listings for all diseases including HIV/AIDS and related conditions.

The majority of U.S. government-sponsored HIV/AIDS trials are conducted by the AIDS Clinical Trials Group (ACTG), a nationwide network of investigators and medical centers. The National Center for Complementary and Alternative Medicine (NCCAM) conducts trials of complementary therapies for conditions related to HIV and its treatment. The HIV Vaccine Trials Network (HVTN) is an international collaboration testing preventive HIV vaccines.

Community Programs for Clinical Research on AIDS (CPCRA) is a nationwide network that conducts community-based clinical trials. In addition to TrialSearch, ACRIA also provides a listing of trials in the mid-Atlantic region. The Community Research Initiative of New England (CRINE) offers a listing of trials in the northeast.

Call the telephone numbers listed for each study or see the indicated Web sites for more information about specific trials. Protocol numbers, if available, are provided in parentheses at the end of each trial description.

TrialSearch

TrialScope

AIDSInfo

ClinicalTrials.gov

CenterWatch

ACTG

NCCAM

HIV Vaccine Trials Network

CPCRA

ACRIA

CRINE


Simplified Kaletra Regimen

Researchers have recently reported data from a study of Kaletra (lopinavir/ritonavir combination pill) used as monotherapy (see "Drug Watch" on page 15). This new, open-label Phase III study, sponsored by Abbott Laboratories, will look at another type of simplified Kaletra regimen. Treatment-naive subjects will be randomly assigned to receive either a standard Kaletra-based regimen containing two nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) or Kaletra plus a single NRTI, tenofovir DF (Viread).

Eligible subjects must be at least 18 years of age and must not have previously taken antiretroviral therapy. They must have a detectable HIV viral load (at least 400 copies/mL), but may have any CD4 cell count. For locations and further information, call Abbott at 800-633-9110. www.clinicaltrials.gov/ct/show/NCT00234910 (ITAL-04-002).

An international Phase II study of Kaletra monotherapy sponsored by the Huesped Foundation is also currently enrolling in Vancouver, Mexico City, and Buenos Aires. One hundred subjects currently taking regimens consisting of Kaletra or another ritonavir-boosted protease inhibitor (PI) plus two NRTIs will have their regimen simplified to Kaletra alone. For more information, see www.clinicaltrials.gov/ct/show/NCT00159224 (ACA-ARGE-04-001).


TMC114: Treatment-Naive and Expanded Access

Researchers at the 2005 International AIDS Society meeting and the Interscience Conference on Antiretroviral Agents and Chemotherapy presented further promising data on TMC114, Tibotec's investigational PI, in treatment-experienced individuals (see "News Briefs" in this issue).

A new Phase III study, sponsored by Tibotec Pharmaceuticals, will compare the efficacy, safety, and tolerability of ritonavir-boosted TMC114 versus Kaletra in people starting anti-HIV therapy for the first time. Subjects will be randomly assigned to receive either TMC114/ritonavir or Kaletra, both with Truvada (emtricitabine/tenofovir combination pill), for 96 weeks. Eligible subjects must be at least 18 years of age, have viral loads of at least 5,000 copies/mL, and be starting antiretroviral therapy for the first time. Subjects may not have active opportunistic illnesses (OIs) or certain laboratory abnormalities. Women may not be pregnant or breast-feeding and participants must agree to use effective contraception. This trial aims to enroll 660 participants at some 25 U.S. sites, including Austin, Baltimore, Ft. Lauderdale, Houston, Los Angeles, Miami, Orlando, Philadelphia, Phoenix, San Francisco, San Juan, Tampa, Winston-Salem, and Washington, DC. For all sites, send e-mail to info@veritasmedicine.com. www.clinicaltrials.gov/ct/gui/show/NCT00258557 (TMC114-C211; CR002800).

In addition to this trial, in October 2005 Tibotec announced the launch of a TMC114 expanded access program (EAP) for people with limited treatment options. The program will provide free access to TMC114 for people with AIDS who need the drug to construct a viable treatment regimen (i.e., have experience with three antiretroviral drug classes, have used at least two PI-based regimens, and have a CD4 cell count of 200 cells/mm3 or less) and who are not eligible for currently enrolling clinical trials. For more about the program, healthcare professionals and people with HIV/AIDS may call 866-889-2074 or send e-mail to TMC114-C226@i3research.com. www.clinicaltrials.gov/ct/show/NCT00245739 (TMC114-C226; CR006304).


TMC125: New NNRTI

Tibotec has also taken the unusual step of conducting clinical trials using two experimental agents, TMC114 and the company's investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC125 (see "News Briefs" in this issue). Two very similar Phase III trials, TMC125-C206 and TMC125-C216 (DUET 1 and 2), will look at the long-term safety, efficacy, and tolerability of regimens containing TMC125. In each study, 600 treatment-experienced HIV positive subjects with limited or no available treatment options will be randomly assigned to receive TMC125 or placebo; all participants will also receive ritonavir-boosted TMC114 plus an optimized background regimen. Eligible subjects must be at least 18 years of age and have HIV viral load greater than 5,000 copies/mL. They must have at least three primary PI resistance mutations as well as resistance to currently available NNRTIs. Exclusion criteria include active OIs, certain abnormal laboratory results, and use of certain medications.

TMC125-206 is enrolling in Little Rock, AK; Macon, GA; Santa Fe, NM; Huntersville, NC; Longview, TX; and Washington, DC. TMC125-216 is enrolling in Palm Springs, Phoenix, and Washington, DC. For both studies, send e-mail to info@veritasmedicine.com. www.clinicaltrials.gov/ct/show/NCT00254046 (CR002752; TMC125-206);
www.clinicaltrials.gov/ct/show/NCT00255099 (CR006307; TMC125-216).


Maraviroc Studies Enrolling

Pfizer is conducting three currently enrolling trials looking at the safety and efficacy of its investigational HIV entry inhibitor maraviroc (UK-427,857), the subject of favorable reports at recent conferences (see "News Briefs" in this issue).

The first Phase II/III study will compare maraviroc against efavirenz (Sustiva) in individuals starting anti-HIV therapy for the first time. Subjects will be randomly assigned to receive 300 mg maraviroc once daily, 300 mg maraviroc twice daily, or efavirenz; all participants will also take AZT (zidovudine, Retrovir) and 3TC (lamivudine, Epivir). Participants will have regular clinic visits, some of which will include physical examinations, blood draws, electrocardiogram (EKG) heart rhythm monitoring, computerized tomography (CT) scans, and symptom questionnaires.

Eligible subjects must be at least 16 years of age and have viral load of at least 2,000 copies/mL. Subjects must have HIV that uses the CCR5 (rather than the CXCR4) coreceptor. Exclusion criteria include various medical conditions or abnormal laboratory results, current or prior use of certain medications, and resistance to study drugs. Women may not be pregnant or breast-feeding and participants must agree to use effective contraception.

This study will enroll more than 1,000 subjects at some 200 centers worldwide, including Atlanta, Birmingham, Boston, Chicago, Cincinnati, Dallas, Denver, Houston, Indianapolis, Los Angeles, Miami, New York City, Oakland, Omaha, Philadelphia, Sacramento, San Francisco, San Juan, Tacoma, and Tampa. For all sites, call Pfizer at 800-718-1021. www.clinicaltrials.gov/ct/show/NCT00098293 (A4001026).

The other two Phase II/III trials will look at the safety and efficacy of maraviroc plus optimized background therapy (OBT). Treatment-experienced individuals will be randomly assigned to receive 150 mg maraviroc once daily, 150 mg maraviroc twice daily, or placebo; all participants will also take OBT determined on the basis of treatment history and resistance testing. Participants will receive regular clinic visits, some of which will include physical examinations, blood draws, and EKGs.

Eligible subjects must be at least 16 years of age and have viral load of at least 5,000 copies/mL. They must have been on stable HAART, or else no antiretroviral therapy, for at least four weeks. Subjects must have at least six months experience with, or documented resistance to, three of the four classes of approved anti-HIV drugs. Exclusion criteria include various medical conditions or abnormal laboratory results and current or prior use of certain medications. Women may not be pregnant or breast-feeding and participants must agree to use effective contraception.

These studies aim to enroll 500 participants at nearly 100 sites in the U.S., including Albany, Albuquerque, Atlanta, Baltimore, Baton Rouge, Birmingham, Boston, Cincinnati, Dallas, Denver, Durham, Houston, Los Angeles, Madison, Miami, Minneapolis, New Orleans, New York City, Oakland, Omaha, Orlando, Philadelphia, Phoenix, Rochester, Sacramento, San Francisco, San Juan, St. Louis, Tacoma, Tampa, Wichita, and Washington, DC, as well as several international locations. For all sites, call Pfizer at 800-718-1021. www.clinicaltrials.gov/ct/show/NCT00098306 (A4001027);
www.clinicaltrials.gov/ct/show/NCT00098722 (A4001028).


New Oral Entry Inhibitor: SP01A

Based on promising Phase I/II results, Samaritan Pharmaceuticals is now enrolling a Phase II monotherapy trial to assess the safety, efficacy, and optimal dosing of its experimental oral entry inhibitor, SP01A, in treatment-experienced individuals. After a 40-day washout period of all current anti-HIV drugs, participants will be randomly assigned to receive one of three doses of SP01A or placebo for 10 days; a 28-day monotherapy study is also underway.

Eligible subjects must be 18-60 years of age and experiencing virological failure despite antiretroviral therapy; CD4 cell count must be at least 50 cells/mm3. Patients currently on stable antiretroviral regimens that are successfully suppressing HIV (below 5,000 copies/mL) are not eligible. Exclusion criteria include various medical conditions (including active OIs or hepatitis) or abnormal laboratory results and use of certain medications (including sulfonamide drugs). Women may not be pregnant or breastfeeding and must agree to use effective contraception.

This study aims to enroll 92 subjects at six sites including Fort Lauderdale (954-564-4222), Fort Worth (817-810-9810), Miami (305-792-2090), Orlando (407-647-3960 ext. 2118), Pittsburgh (412-661-17163), and Tampa (813-875-4374). www.clinicaltrials.gov/ct/show/NCT00113412 (SP01A-105-04).


Fixed Dose Combination Pills

This randomized Phase IV postmarketing study, sponsored by GlaxoSmithKline, will compare the long-term safety and efficacy of two double-NRTI fixed-dose combination pills -- Glaxo's Epzicom (abacavir/3TC) and Gilead Sciences' Truvada (emtricitabine/tenofovir) -- used in combination with Kaletra for 96 weeks.

Eligible subjects must be at least 18 years of age, have viral loads of at least 1,000 copies/mL, and be starting antiretroviral therapy for the first time. Subjects may not have active OIs, pancreas or kidney dysfunction, or active hepatitis, and may not be taking medications that may interfere with the study drugs. Women may not be pregnant, breast-feeding, or planning to become pregnant during the two-year study period, and must use effective contraception.

This study will enroll 680 subjects at nearly 100 sites including Atlanta, Austin, Baltimore, Charlotte, Chicago, Denver, Detroit, Houston, Las Vegas, Los Angeles, Louisville, Miami, Milwaukee, Newark, New Orleans, New York City, Oakland, Orlando, Philadelphia, Rochester, San Francisco, San Juan, St. Louis, Tampa, Toledo, Tucson, Tulsa, and Washington, DC. For all sites, call Glaxo at 877-379-3718. www.clinicaltrials.gov/ct/show/NCT00244712 (EPZ104057).


SLAM-C: Pegylated Interferon Maintenance Therapy for HIV/HCV Coinfection

Past research has shown that liver damage due to hepatitis C progresses more rapidly in HIV positive people. Coinfected people do not respond as well to hepatitis C treatment as individuals with hepatitis C virus (HCV) alone, but some studies suggest that long-term interferon maintenance therapy may help slow liver disease progression even in the absence of a sustained virological response.

In this open-label Phase II study, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), subjects who either have never received therapy for hepatitis C or who did not clear HCV with prior treatment will receive a standard course of HCV therapy (180 mcg Pegasys brand pegylated interferon-alfa-2a once weekly plus weight-based ribavirin daily). Subjects who respond well after 12 weeks will continue on this regimen for an additional 60 weeks. Those who respond poorly will be randomly assigned either to stop ribavirin and continue pegylated interferon for 72 weeks, or to discontinue both ribavirin and pegylated interferon. Follow-up will continue for 90-96 weeks. Participants will receive liver biopsies at study entry, after changing therapy, and at the end of follow-up to monitor progression of fibrosis (liver scarring).

Eligible participants must be at least 18 years of age and have chronic hepatitis C with elevated liver enzyme (ALT, AST, and alkaline phosphatase) levels and at least stage I fibrosis. They must have been on stable anti-HIV therapy for at least eight weeks or else off antiretroviral therapy for four weeks. They must have HIV viral load below 50,000 copies/mL and CD4 cell counts of at least 200 cells/mm3. They must either be naive to hepatitis C therapy or else still have detectable HCV RNA after previous treatment with standard or pegylated interferon with or without ribavirin. Exclusion criteria include various medical conditions (including decompensated liver cirrhosis, hepatitis B, autoimmune diseases, and uncontrolled depression or other psychiatric conditions) and current or prior use of certain medications. Women may not be pregnant or breast-feeding and participants must agree to use effective contraception.

This study aims to enroll 180 subjects at more than 40 sites, including Atlanta (404-616-6313), Baltimore (410-614-2766), Birmingham (205-975-7925), Boston (617-724-0072), Buffalo (716-898-3933), Chapel Hill (919-843-8761), Chicago (312-695-5012), Cincinnati (513-584-8373), Cleveland (216-778-5489), Dallas (214-590-0414), Denver (303-372-5535), Galveston (409-747-0241), Honolulu (808-737-2751), Indianapolis (317-630-6023), Los Angeles (310-825-1301), Miami (305-243-3838), Nashville (615-467-0154 ext. 108), New York City (212-746-7198), Omaha (402-559-8163), Philadelphia (215-349-8092), Pittsburgh (412-647-0771), Providence (401-793-4396), Rochester (585-275-2740), San Francisco (415-514-0550 ext. 354), San Juan (787-759-9595), St. Louis (314-454-0058), and Washington, DC (202-687-7387). www.clinicaltrials.gov/ct/show/NCT00078403 (ACTG A5178; SLAM-C).


Nucleoside Supplement for Lipoatrophy

This open-label Phase II study, sponsored by NIAID, will assess whether use of a nucleoside-rich nutritional supplement or switching from the thymidine analog NRTIs AZT or d4T (stavudine, Zerit) to tenofovir can help reverse peripheral fat loss (lipoatrophy) believed to be associated with mitochondrial toxicity in people with HIV. The supplement, NucleomaxX, is a sugar cane extract containing the nucleoside uridine, a building block of genetic material. The researchers hypothesize that nucleoside supplementation may help counteract the adverse effects of NRTIs by increasing mitochondrial DNA in fat tissue; preliminary data suggest that NucleomaxX can help alleviate lipoatrophy related to AZT or d4T (see "Nutrition and HIV" on page 27). Participants will be randomly assigned to receive NucleomaxX every other day for 48 weeks, or to switch from AZT or d4T to tenofovir. Subjects will have 10 study visits, which will include blood draws and other tests.

Eligible participants must be at least 18 years of age with HIV viral load below 50 copies/mL and diagnosed HIV-related lipoatrophy. They must be on stable antiretroviral regimens that include AZT or d4T. Exclusion criteria include certain medical conditions (including diabetes requiring medication) and abnormal laboratory tests. Women may not be pregnant or breastfeeding.

This study will enroll 50 subjects at the University Hospitals of Cleveland (216-844-2460). www.clinicaltrials.gov/ct/show/NCT00119379 (1R01-AI060484-01A2B).


L-Carnitine for Fatigue

This Phase II study, sponsored by the National Institute of Nursing Research, will examine whether supplementation with the micronutrient levocarnitine (L-carnitine), which plays a role in energy metabolism, can help alleviate fatigue and related symptoms in carnitine-deficient subjects with AIDS. Participants will be randomly assigned to receive either L-carnitine or placebo; after two weeks, all participants who initially received the placebo will be switched over to L-carnitine, and everyone will continue on L-carnitine for two more weeks.

Eligible participants must be at least 18 years of age with diagnosed AIDS (stage IV-C) and persistent clinically significant fatigue. Subjects may not have certain medical conditions, including history of seizure disorders, dementia, or cognitive impairment.

This study aims to enroll 44 participants at Beth Israel Medical Center in New York City (212-420-4748). www.clinicaltrials.gov/ct/show/NCT00079599 (1 R21 NR08295-01).


Nutritional Supplement for Insulin Resistance

This Phase II/III study, sponsored by the National Center for Complementary and Alternative Medicine, will assess whether use of the nutritional supplement chromium picolinate can help reduce insulin resistance or glucose intolerance -- a precursor to diabetes -- in people with HIV. Previous research suggests that chromium picolinate helps improve insulin sensitivity in HIV negative individuals with type 2 diabetes mellitus. Participants will be randomly assigned to receive either chromium picolinate or placebo once daily for two months. There will be four overnight visits plus two additional daytime visits.

Eligible participants must be at least 18 years of age and currently taking combination antiretroviral therapy. They must have HIV viral load below 35,000 copies/mL and CD4 cell counts of at least 300 cells/mm3. Exclusion criteria include certain medical conditions (including diabetes requiring medication) and abnormal laboratory tests. Women may not be pregnant.

This study will enroll 40 participants at the State University of New York General Clinical Research Center in Stony Brook (631-444-1175). www.clinicaltrials.gov/ct/show/NCT00109746 (AT002499-01A1).


Protease Inhibitors and Glucose Metabolism

This randomized Phase IV study, sponsored by the Department of Veterans Affairs, will attempt to determine how PIs contribute to the development of diabetes in people with HIV -- in particular, whether PIs impair insulin secretion and increase the production of glucose by the liver. In order to separate out the effects of PIs from those of HIV itself, this study will use HIV negative volunteers. Participants will be randomly assigned to receive either a single dose of a PI or placebo. Somatostatin and growth hormone will be administered to control insulin and glucagon production. Insulin secretion will be assessed using the hyperglycemic clamp technique. Liver glucose production will be measured in the fasting and hyperinsulinemic (excess insulin) states.

This study aims to enroll 80 healthy, HIV negative participants between 18 and 72 years of age. Volunteers may not have medical conditions associated with insulin resistance, such as obesity or elevated blood fat levels, and may not be taking glucocorticoids, growth hormone, niacin, or antipsychotic medications. Women may not be pregnant. This study will take place at the San Francisco Veterans Affairs Medical Center (415-221-4810 ext. 2118). www.clinicaltrials.gov/ct/show/NCT00259727 (RCD-005-05S; H574-23263).


Kaletra for HIV Positive Infants

This nonrandomized, open-label Phase I study, sponsored by NIAID and the National Institute of Child Health and Human Development (NICHD), will assess the safety and tolerability of the PI Kaletra in HIV positive infants up to six months old; the drug is currently approved for adults and children over six months of age. The study also aims to determine the most effective Kaletra dose for infants, and whether early anti-HIV therapy promotes normal immune system development. Infants will receive Kaletra plus two NRTIs chosen by their physicians. They will have study visits every two weeks for the first eight weeks, then every four weeks until the end of the first year, then every 12 weeks; some visits will include pharmacokinetic monitoring. Infants will be followed for two years after the enrollment of the last participant.

Eligible infants must be between 14 days and six months of age and weigh more than 5.5 pounds (2.5 kilograms). They must have diagnosed HIV infection, with HIV viral load greater than 10,000 copies/mL within 30 days prior to study entry. Exclusion criteria include certain medical conditions (including active OIs), abnormal laboratory tests, and use of certain medications (including NNRTIs and other PIs).

This study will enroll 26 infants at more than 20 U.S. sites, including Baltimore (410-955-9749), Boston (617-355-8198), Chapel Hill (919-966-9110), Chicago (773-880-3669), Denver (303-861-6751), Durham (919-416-3447), Jacksonville (904-244-5331), Memphis (901-495-3490), Miami (305-243-4447), Newark (973-972-3118), New Orleans (504-586-3804), New York City (212-263-5680), Oakland (510-428-3885 ext. 2827), San Diego (619-543-8080), San Francisco (415-476-6480), San Juan (787-765-4186), and Washington, DC (202-865-4578). www.clinicaltrials.gov/ct/show/NCT00038480 (PACTG P1030).


Kaletra Interaction With the Contraceptive Patch

Past research has shown that several PI and NNRTI drugs interact with oral contraceptives; however, this may be less of a concern with a transdermal contraceptive patch that bypasses the common metabolic pathway. This nonrandomized Phase II study, sponsored by NIAID, will assess interactions between Kaletra (lopinavir/ritonavir) and hormonal oral and transdermal contraceptives. Women will receive a single dose of the Ortho Novum 1/35 contraceptive pill on the first day of the study and will start the Ortho Evra contraceptive patch on the third day. Blood levels of lopinavir and the hormone ethinyl estradiol will be measured throughout the six-week trial; liver enzyme levels and hormonal side effects will also be assessed.

Eligible women must be at least 13 years of age and weigh no more than 198 pounds (90 kilograms); women over age 35 must be nonsmokers. Women may be either HIV positive or HIV negative, with HIV viral load below 55,000 copies/mL and CD4 cell counts of at least 200 cells/mm3. They may be on a regimen containing Kaletra for at least 60 days prior to study entry, or on a NRTI-only regimen, or not taking any antiretroviral therapy for at least 30 days. Exclusion criteria include certain medical conditions (including cardiovascular or liver disease) and recent use of certain medications (including systemic hormonal therapies or glucocorticoids, NNRTIs, or tenofovir). Participants may not be pregnant, and will receive a pregnancy test at study entry.

This study aims to enroll 54 women at eight sites including Baltimore (410-706-1476), Chicago (773-257-5717), Denver (303-372-5535), Honolulu (808-737-2751), Los Angeles (323-226-2226), New Haven (203-688-6093), and Seattle (206-731-8877). www.clinicaltrials.gov/ct/show/NCT00125983 (AACTG A5188).


Tenofovir to Prevent Perinatal HIV Transmission

Recent data showing that single-dose nevirapine for prevention of mother-to-child transmission (MTCT) can lead to rapid resistance have spurred the search for other convenient and inexpensive perinatal prevention strategies.

This Phase I trial, sponsored by NIAID and NICHD, will look at the safety, tolerability, and pharmacokinetics of single-dose tenofovir given to women during labor and to their newborn infants. Tenofovir has been shown to effectively reduce MTCT in monkeys infected with a simian virus related to HIV. In this nonrandomized, open-label study, pregnant women will be assigned to one of two groups. Subjects in Cohort 1 will receive a single 600 mg dose of tenofovir at the start of labor or before planned cesarean section. They will also receive intravenous AZT (standard therapy for preventing MTCT in developed countries) and/or other antiretroviral medications prescribed by their physicians. Infants born to women in Cohort 1 will receive the standard six-week postpartum AZT prophylaxis regimen. After eight-week data from infants in Cohort 1 have been analyzed, a second cohort of pregnant women will receive single-dose tenofovir (with the dose to be determine based on pharmacokinetic data from Cohort 1) plus standard AZT prophylaxis and/or other antiretroviral drugs. Infants born to women in Cohort 2 will receive a single dose of tenofovir six hours after birth along with the standard AZT regimen. Several blood samples will be collected from mothers and infants. The women will be followed for 12 weeks postpartum; if viral resistance to tenofovir emerges during this period, they will be followed for two years. The infants will be followed until age 2.

Eligible women must be at least 18 years of age and in their third trimester of pregnancy (at least 34 weeks gestation). There are no viral load or CD4 cell count restrictions. Exclusion criteria include various medical conditions, abnormal laboratory results, and current or prior use of certain medications. Ultrasound screening must show a normal pregnancy and mothers must agree not to breast-feed.

This study aims to enroll 20 women at more than 20 sites including Boston (617-355-8198), Bronx (718-960-1020), Chicago (773-257-5717), Denver (303-861-6751), Detroit (313-745-7857), Durham (919-416-3447), Houston (832-824-1339), Los Angeles (323-226-2226), Memphis (323-669-2390), Miami (305-243-4447), Newark (973-972-3118), New York City (212-263-5680), Philadelphia (215-427-5284), San Diego (619-543-8080), and San Juan (787-765-4186). www.clinicaltrials.gov/ct/show/NCT00076791 (PACTG 394).


Treatment During Early Infection

While some experts believe antiretroviral therapy should be started soon after HIV infection, it is not yet clear whether treatment of recently infected individuals leads to long-term benefit or harm. In this open-label study, sponsored by NIAID, participants newly infected with HIV will be randomly assigned to receive either no treatment or a regimen of Truvada (emtricitabine/tenofovir combination pill) plus Kaletra for 36 weeks; after 36 weeks, subjects in both arms will have the option to continue or start treatment if they have high viral load, low CD4 count, or HIV-related symptoms. HIV viral load will be measured at the end of treatment and at 72 and 96 weeks to determine whether early therapy appears to lower the viral "set point"; CD4 cell count, occurrence of AIDS-defining illnesses, adverse side effects, and drug resistance will also be assessed. Study visits will occur every 2-4 weeks for the duration of the 96-week trial.

Eligible subjects must be at least 18 years of age. They must be recently infected with HIV, with viral load of at least 500 copies/mL and CD4 cell counts of at least 350 cells/mm3 within 21 days prior to study entry. Exclusion criteria include various medical conditions and use of certain medications (including prior antiretroviral therapy or investigational HIV vaccines). Women may not be pregnant or breast-feeding.

This study aims to enroll 150 participants at more than 30 sites including Atlanta (404-616-6313), Boston (617-724-0070), Chapel Hill (919-843-8761), Denver (303-372-5535), Detroit (313-916-2570), Durham (919-684-8216), Indianapolis (317-274-8456), New York City (212-327-7281), Philadelphia (215-349-8092), Providence (401-793-4396), Rochester (585-275-2740), San Diego (619-543-8080), San Francisco (415-476-9296 ext. 318), Seattle (206-731-8877), and St. Louis (314-454-0058). www.clinicaltrials.gov/ct/show/NCT00090779 (ACTG A5217; AIEDRP AIN503).

Subjects in this trial will also be encouraged to join AIEDRP CORE01, a long-term follow-up study of HIV positive individuals identified during early infection. www.clinicaltrials.gov/ct/show/NCT00086372.


Project T: Tenofovir to Prevent HIV Infection

This study, conducted by the Centers for Disease Control and Prevention (CDC) in conjunction with the San Francisco Department of Public Health (SFDPH), will attempt to determine whether tenofovir can help prevent HIV infection. The drug has performed well in animal prevention studies and it has fewer side effects than most other antiretroviral medications. Participants will receive either daily oral tenofovir or placebo. This phase of the study will focus on the clinical and behavioral safety of the drug rather than its effectiveness. In particular, researchers will attempt to determine whether using a potentially preventive drug will lead to an increase in risky sexual behavior. Because it is not yet known whether tenofovir can help prevent HIV infection -- and because some subjects will receive placebo -- participants should continue to practice safer sex, and will receive risk-reduction counseling and free condoms. Should any participants become infected, SFDPH will facilitate referrals for HIV care and treatment.

Eligible participants must be sexually active HIV negative men who have sex with men. The study is expected to last two years. The U.S. arm of the study will enroll 400 gay and bisexual men in San Francisco (415-554-9068; www.sfaidsresearch.org) and Atlanta. The CDC is conducting similar studies in Botswana and Thailand looking at heterosexual and injection drug-using populations.


ACE: Herpes Suppression to Prevent HIV Infection

The ACE study, also conducted by SFDPH, will examine whether suppression of genital herpes (herpes simplex virus type 2, or HSV-2) with acyclovir (Zovirax) can help reduce the risk of contracting HIV. Research to date suggests that having even subclinical (asymptomatic) HSV-2 infection without obvious lesions can increase the likelihood of contracting or transmitting HIV. Participants will be randomly assigned to receive either 400 mg acyclovir or placebo twice daily for 12 months. Those who develop genital herpes outbreaks will be treated with open-label acyclovir. Subjects will also receive risk-reduction counseling and free condoms. Study visits will take place every month and participants will be compensated for their time.

Eligible participants must be sexually active HIV negative gay or bisexual men at least 18 years of age with confirmed HSV-2 infection. The study will enroll some 300 participants in San Francisco (415-437-4782; www.sfaidsresearch.org). There are other study sites for men who have sex with men in Seattle (206-520-3800 or 800-464-9063), New York City (212-388-0008; www.projectachieve.org), and Lima, Peru. A similar study of heterosexual women is being conducted in Zimbabwe, Zambia, and South Africa. www.hptn.org/research_studies/hptn039.asp (HTPN 309).


Reinfection With New HIV Strains

Some research suggests that reinfection (or superinfection) with new strains of HIV may lead to faster disease progression (see "Dual Infection" in this issue). The Positive Partners study will investigate the incidence of reinfection with genetically distinct viral strains -- in particular drug-resistant strains -- in HIV positive couples. Participants will have two confidential, one-on-one interviews over the course of one year, during which they will provide blood and (if male) semen samples. If viral load increases by 1 log, an additional visit may be necessary. Drug resistance tests will be conducted at least twice during the year and results will be provided to participants. Subjects will be reimbursed $35 for each visit.

Eligible participants must be at least 18 years of age, taking antiretroviral therapy, and have a sexual partner who is also HIV positive and taking anti-HIV treatment. There are no CD4 cell count or viral load restrictions. The study will take place in San Francisco. For more information, call 415-734-4878 or send e-mail to positivepartners@gladstone.ucsf.edu.

www.gladstone.ucsf.edu/gladstone/site/pospart/.


Buprenorphine and HIV Primary Care

This Phase IV study, sponsored by the University of California at San Francisco (UCSF), the New York Academy of Medicine, and the federal Health Resources and Services Administration, will assess the feasibility, effectiveness, and cost of integrating buprenorphine treatment for opiate dependence in an HIV primary care setting. Opiate-using subjects will receive HIV primary care from UCSF's Positive Health Program at San Francisco General Hospital. They will be randomly assigned to receive 12 months of opiate-replacement therapy with buprenorphine either as part of their primary care or at a separate substance abuse treatment clinic. The study will look at the program's effects on participant's substance use and overall health.

Eligible subjects must be at least 19 years of age, meet the DSM-IVR criteria for opioid dependence, and plan to remain in San Francisco for 12 months. Exclusion criteria include coexisting alcohol or benzodiazepine dependence, liver dysfunction, certain types of psychiatric impairment, and certain other medical conditions. Women may not be pregnant or trying to become pregnant.

For more information, call 415-476-9296 ext. 311 or send e-mail to rthawley@php.ucsf.edu. www.clinicaltrials.gov/ct/show/NCT00263458 (H97HA03799).


Back to the SFAF BETA Winter 2005/2006 contents page.

This article was provided by San Francisco AIDS Foundation, and is a part of the publication Bulletin of Experimental Treatments for AIDS.


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