October 31, 2012
Other Names: ACH-126443, L-F-D4C
Drug Class: Nucleoside Reverse Transcriptase Inhibitors
Elvucitabine is an investigational drug for the treatment of HIV infection.
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.
Clinical trials are conducted in "phases." Each phase has a different purpose and helps researchers answer different questions.
An investigational drug must be proven safe and effective in a Phase III clinical trial to be considered for traditional approval by the FDA for sale in the United States. Some drugs go through the FDA's accelerated approval process and are approved before a Phase III clinical trial is complete. After a drug is approved by the 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.
Elvucitabine has been studied in Phase II clinical trials.
In a Phase II study, elvucitabine taken once daily was compared with lamivudine in HIV-infected, treatment-naive participants. All study participants also received tenofovir disoproxil fumarate (brand name: Viread) and efavirenz (brand name: Sustiva) as part of their background regimens. (A background regimen is a combination of drugs that are not being studied as the investigational drug[s] in the clinical trial, but are being given to help control a participant's HIV infection.)
In this study, using an as-treated analysis (looking at data from the participants who completed the full length of the trial), elvucitabine proved as effective as lamivudine, with similar numbers of patients in both treatment arms experiencing reductions in viral load after 96 weeks. However, using an intention-to-treat anaylsis (looking at data from all study participants, including those who discontinued the study), fewer participants in the elvucitabine treatment arm had a virologic response than in the lamivudine arm. This difference is because of the higher proportion of study drop-outs in the elvucitabine arm than in the lamivudine arm. In terms of safety, elvucitabine was comparable to lamivudine. One participant discontinued elvucitabine due to a drug-related side effect.
An additional Phase II study of elvucitabine in HIV-infected, treatment-experienced adults with the M184V HIV resistance mutation was completed.
More information on testing of elvucitabine is available from these sources:
More information about elvucitabine-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.
Clinical trials involve benefits and risks. Before deciding to participate in a clinical trial, talk to your health care provider. For more information on participating in clinical trials, visit NIH Clinical Research Trials and You.