January 4, 2018
Other Names: 4'-Ed4T, 4'-ethynyl-d4T, 4'-ethynylstavudine, BMS-986001, OBP-601, festinavir
Drug Class: Nucleoside Reverse Transcriptase Inhibitors
Molecular Formula: C12 H12 N2 O4
Registry Number: 634907-30-5 (CAS)
Chemical Name: 1-[(2R,5R)-5-ethynyl-5-(hydroxymethyl)-2H-furan-2-yl]-5-methyl-pyrimidine-2,4-dione
Chemical Class: Pyrimidine Nucleosides
Company: Oncolys BioPharma
Phase of Development: IIb
(Compound details obtained from ChemIDplus Advanced,1 NIAID Therapeutics Database,2 and Oncolys BioPharma website3)
An investigational drug is one that is under study and is not approved by the U.S. Food and Drug Administration (FDA) for sale in the United States. Medical research studies are conducted to evaluate the safety and effectiveness of an investigational drug. These research studies are also called clinical trials. Once an investigational drug has been proven safe and effective in clinical trials, FDA may approve the drug for sale in the United States.
To learn more about investigational drugs, read the AIDSinfo What is an Investigational HIV Drug? fact sheet.
Censavudine is an investigational drug that is being studied for the treatment of HIV infection.
Censavudine belongs to a class (group) of HIV drugs called nucleoside reverse transcriptase inhibitors (NRTIs).2 NRTIs block an HIV enzyme called reverse transcriptase. (An enzyme is a protein that starts or increases the speed of a chemical reaction.) By blocking reverse transcriptase, NRTIs prevent HIV from multiplying and can reduce the amount of HIV in the body.
Censavudine is similar in chemical structure to the FDA-approved NRTI stavudine (brand name: Zerit). However, in vitro studies have shown that censavudine may be more effective than stavudine and may be less toxic than stavudine and other NRTIs.4,5 (In vitro studies are studies done in test tubes or other laboratory equipment and not on animals or humans.) Research in animals has shown that censavudine is not associated with kidney or bone toxicities.6
Clinical trials are conducted in phases. Each phase has a different purpose and helps researchers answer different questions.7
In most cases, an investigational drug must be proven effective and must show continued safety in a Phase III clinical trial to be considered for approval by FDA for sale in the United States. Some drugs go through FDA's accelerated approval process and are approved before a Phase III clinical trial is complete. After a drug is approved by FDA and made available to the public, researchers track its safety in Phase IV trials to seek more information about the drug's risks, benefits, and optimal use.7
Some clinical trials are categorized as "a" or "b," such as "Phase Ia" or "Phase IIb." These different subphases typically mean that a study is researching certain types of information or using a certain type of participant population.
Censavudine has been studied in a Phase IIb clinical trial.2
Study Name: EudraCT 2008-004810-29
Funding Organizations: Oncolys Pharma and Bristol-Myers Squibb
Status: This study has been completed.
One goal of HIV research is to identify new drugs that have fewer side effects. The following side effects were observed in some of the studies of censavudine listed above.
In this 10-day Phase IIa study, the most common side effects that occurred in the censavudine groups were abdominal pain, swollen lymph nodes, nausea, headache, and fatigue.8
In this Phase IIb study, participants in the censavudine groups had a smaller decline in bone mineral density than the participants in the group that did not receive censavudine. (Bone mineral density is a measurement of the amount of minerals, such as calcium, in an area of the bone.) There was a trend towards a build-up of limb and trunk fat with censavudine treatment, especially at the highest dose tested. Also, a slight increase in total cholesterol was seen with censavudine treatment.10
Because censavudine is still being studied, information on possible side effects of the drug is not complete. As testing of censavudine continues, additional information on possible side effects will be gathered.
More information about censavudine-related research studies is available from the AIDSinfo database of ClinicalTrials.gov study summaries. Click on the title of any trial in the list to see the ClinicalTrials.gov trial summary and more information about the study.
Participating in a clinical trial can provide benefits. For example, a volunteer participant can benefit from new research treatments before they are widely available. Participants also receive regular and careful medical attention from a research team that includes doctors and other health professionals. However, clinical trials may also involve risks of varying degrees, such as unpleasant, serious, or even life-threatening side effects from the treatment being studied.7
Your health care provider can help you decide whether participating in a clinical trial is right for you. For more information, visit NIH Clinical Research Trials and You.
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