Table of Contents
Below is a selection of currently enrolling clinical trials of antiretroviral therapy (ART), and therapies for HIV/AIDS-related conditions.
The federal government's AIDSinfo website includes a clinical trials section featuring 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 email (ContactUs@AIDSinfo.nih.gov), a toll-free telephone service (800-448-0440; international 301-315-2816), and an interactive website.
AIDSInfo recently expanded its Live Help chat service (http://aidsinfo.nih.gov/LiveHelp/Default.aspx) to enable users to interact in real time with specialists who can assist with clinical trial searches; when navigating through the trials search page, a pop-up window will appear with a chat invitation. Live Help is available Monday through Friday, 9:00 a.m. to 1:00 p.m. Pacific Time; telephone assistance is available from 9:00 a.m. to 2:00 p.m.
Most U.S. government HIV/AIDS treatment trials are conducted by the AIDS Clinical Trials Group (ACTG). HIV prevention trials fall under the auspices of the HIV Prevention Trials Network (HPTN), the HIV Vaccine Trials Network (HVTN) and the Microbicide Trials Network (MTN). The other two trials networks funded by the National Institutes of Health are International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) and the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT). The National Center for Complementary and Alternative Medicine (NCCAM) conducts trials of complementary therapies for all conditions, including HIV/AIDS.
TrialSearch, operated by the AIDS Community Research Initiative of America (ACRIA), is a searchable online database of clinical trials related to HIV/AIDS and treatment for HIV-associated illnesses. CenterWatch is a commercial website that includes trial listings for all diseases, including HIV/AIDS and related conditions. Trials of new drugs sponsored by pharmaceutical companies are often listed on company websites as well as ClinicalTrials.gov.
Call the telephone numbers listed for each study or see the indicated websites for further information about specific trials. Protocol numbers, if available, are provided in parentheses at the end of each trial description.
Gilead Sciences is sponsoring a study to evaluate the safety and efficacy of a single-tablet regimen containing Tibotec's new non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine (formerly TMC278) plus tenofovir/emtricitabine (the drugs in Truvada) among people currently on another antiretroviral regimen (see "Rilpivirine Shows Potent Activity," in this issue, for more information about rilpivirine).
This open-label Phase III trial will enroll HIV positive participants who have been on a regimen consisting of a boosted protease inhibitor plus two nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for at least six months, and have a stably suppressed viral load. They will be randomly assigned to either remain on their current regimen or switch to the rilpivirine combination tablet (25 mg rilpivirine/300 mg tenofovir/200 mg emtricitabine), administered once-daily with a meal. Investigators will assess whether the new tablet is noninferior to protease inhibitor regimens at 24 weeks. After this analysis, participants initially assigned to stay on their old regimen will switch to the new tablet.
Eligible participants must be at least 18 years of age. They must be on their first or second protease inhibitor regimen and have stable undetectable viral load (at least two undetectable HIV RNA measurements within the past six months and below 50 copies/mL at study screening). They must be NNRTI-naive, with no previous use of any approved or experimental drugs in this class and must have a genotypic test showing no resistance to the study drugs. People on their second regimen may not have experienced prior treatment failure. Exclusion criteria include active AIDS-defining conditions, recent malignancies, liver or kidney impairment, certain laboratory abnormalities and use of certain other medications, including other experimental drugs. Women may not be pregnant or breastfeeding, and both women and men of childbearing potential must use effective contraception.
This study aims to enroll 420 participants at more than 100 U.S. sites (as well as sites in Canada and Europe), including Atlanta (404-876-2317 ext. 357), Austin (512-480-9660), Birmingham (205-996-5165), Boston (617-502-1700), Charlotte (704-446-1642), Chicago (four sites), Fort Lauderdale (three sites), Houston (three sites), Little Rock (501-603-0003), Los Angeles (five sites), Minneapolis (612-873-2297), Newark (973-877-2663), New York (212-420-4005), Oakland (510-437-4373), Orlando (407-647-3960 ext. 21005), Philadelphia (three sites), San Francisco (415-833-3487), San Juan, PR (787-723-5945), Seattle (206-624-1441), St. Louis (314-647-2200) and Washington, D.C. (202-745-6111). www.clinicaltrials.gov/ct2/show/NCT01252940 (GS-US-264-0106, 2010-023178-37).
The Shionogi-ViiV Healthcare collaboration has started a Phase III clinical trial for treatment-naive individuals to test its experimental integrase inhibitor GSK1349572 (or GSK572 for short; see "GSK572 Integrase Inhibitor Shines In Phase II," in this issue, for more information).
This randomized, double-blind study will assess whether 50 mg once-daily GSK572 is noninferior to 400 mg twice-daily raltegravir (Isentress, the sole approved integrase inhibitor), both used in combination with a dual NRTI fixed-dose combination pill (abacavir/lamivudine [Combivir] or tenofovir/emtricitabine [Truvada]). Efficacy will be compared at 48 and 96 weeks.
Participants must be at least 18 years of age and be starting antiretroviral therapy for the first time. They must have a viral load of at least 1,000 copies/mL. Exclusion criteria include active AIDS-defining conditions, malignancies, liver impairment, serious laboratory abnormalities and recent use of certain other medications or vaccines. Women may not be pregnant or breastfeeding and must use effective contraception.
The study aims to enroll nearly 800 participants in the U.S., Europe and Australia. U.S. sites include Atlanta, Austin, Charlotte, Dallas, Denver, Fort Pierce, Hillsborough (NJ), Houston, Little Rock, Long Beach, Los Angeles, Phoenix, St. Louis and Washington, D.C. For all sites, contact the U.S. GSK Clinical Trials Call Center (877-379-3718) or email firstname.lastname@example.org. www.clinicaltrials.gov/ct2/show/NCT01227824 (ING113086).
The INSIGHT START (Strategic Timing of Antiretroviral Treatment) trial -- cosponsored by the U.S. National Institutes of Health, the European AIDS Treatment Network and other agencies -- aims to provide further information about the optimal time to initiate ART. Investigators will assess whether the risk of serious illness or progression to AIDS is lower if participants start taking ART when their CD4 cell count is still relatively high, instead of waiting until it falls to the level at which there is currently good evidence for starting treatment. (See "When to Start Antiretroviral Treatment: A Changing Equation," BETA, Summer 2008).
In this open-label Phase IV study, participants with well-preserved immune function, indicated by a CD4 cell count above 500 cells/mm3, will be randomly assigned to either start ART immediately or defer treatment until their CD4 count falls below 350 cells/mm3 or they show signs of progression to AIDS. ART regimens will be selected by study physicians in accordance with national treatment guidelines and may include any approved drugs. The study is expected to continue for 4.5 years, with follow-up visits every four months. Investigators will compare incidence of AIDS-defining events and serious non-AIDS-related disease in the two groups. Other outcomes, including neurocognitive and blood vessel function, will be assessed in smaller subgroups.
Participants must be at least 18 years of age, treatment-naive and have a CD4 cell count above 500 cells/mm3. Exclusion criteria include clinical events indicating HIV disease progression, recent use of certain drugs and certain recent illnesses, including cardiovascular events, non-AIDS-defining cancer and serious liver or kidney impairment. Women may not be pregnant or breastfeeding and must agree to use approved contraception.
START aims to enroll 4,000 participants worldwide. U.S. study sites include Bethesda (301-319-8673), Boston (617-505-1711), the Bronx (718-901-6346), Chicago (312-413-8966), Denver (303-602-8712), Detroit (313-916-2570), Fort Sam Houston (210-916-7843), Minneapolis (612-873-7678), Newark (973-972-1268), New Haven (203-785-3557), New Orleans (504-988-1971), New York (212-939-2957), Orlando (407-647-3960 ext. 2136), Philadelphia (215-707-8846), Portland, OR (503-229-8428), Richmond (804-828-2477), San Diego (619-532-5889), Tampa (813-307-8015 ext. 6460) and Washington, D.C. (202-745-8000 ext. 7558). www.clinicaltrials.gov/ct2/show/NCT00867048 or http://insight.ccbr.umn.edu/start (0603M83587, U01AI068641, 2008-006439-12).
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