Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Miami, Florida 33133


Purpose:

The purpose of this study is to compare the effectiveness of treatment with BMS-232632 to that of efavirenz (EFV) when both are used with zidovudine (ZDV) and lamivudine (3TC).


Study summary:

This is a multinational, 2-arm study. Patients in 1 arm receive BMS-232632 plus EFV placebo capsules. Patients in the other arm receive EFV plus BMS-232632 placebo. Both arms also receive a fixed dose of ZDV-3TC.


Criteria:

Inclusion Criteria Patients may be eligible for this study if they: - Have a viral load of 2,000 or more copies/ml and a CD4 cell count of 100 or more cells/mm3 (or 75 or more cells/mm3 with no prior history of AIDS-defining diagnosis) within 2 weeks before randomization. - Are at least 16 years old. - Have signed consent of parent or guardian if under 18 years of age. - Are willing to use effective barrier methods of birth control. - Are available for follow-up for at least 52 weeks. Exclusion Criteria Patients will not be eligible for this study if they: - Have had anti-HIV treatment within 30 days before screening. - Have a recently diagnosed HIV-related infection. - Have any medical condition requiring treatment at enrollment. - Have recently become HIV infected. - Have acute hepatitis within 30 days of study entry. Certain patients with chronic hepatitis will be eligible. - Expect to need or have taken drugs with myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months before study. Expect to need methadone, ribavirin/interferons, neurotoxic drugs or drugs that affect CYP3A4. - Abuse alcohol or drugs. - Have severe diarrhea within 30 days before study entry. - Are pregnant or breast-feeding. - Have a history of hemophilia. - Have a history of bilateral peripheral neuropathy. - Cannot take medicines by mouth. - Have any other conditions that the doctor thinks would interfere with the study.


NCT ID:

NCT00013897


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Miami, Florida 33133
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.