October 22, 2012
Other Names: Prodrug of BMS-626529
Drug Class: Entry and Fusion Inhibitors
BMS-663068 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.
BMS-663068 is currently being studied in Phase II clinical trials.
In an early Phase II study, two different strengths of BMS-663068 were investigated in both treatment-experienced and treatment-naive HIV-infected participants. Treatment-experienced participants were required to be off anti-HIV therapy for at least 8 weeks prior to starting BMS-663068. Study participants included only those who were infected with HIV-1 subtype B. BMS-663068 was given either once or twice daily, with and without the booster drug ritonavir (brand name: Norvir), an FDA-approved protease inhibitor. A control arm was not used in this trial. Study participants did not receive additional anti-HIV drugs as part of a background regimen. (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, BMS-663068 was shown to have substantial antiviral activity, decreasing viral load from baseline. Investigators concluded that BMS-663068 may be given either once or twice daily and with or without a ritonavir booster. In terms of safety, BMS-663068 was well tolerated. The most common side effects were headache and rash.
An additional Phase II trial of BMS-663068 in treatment-experienced participants is under way.
More information on testing of BMS-663068 is available from these sources:
More information about BMS-663068-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.