HIV Infections
Conditions
Keywords
Placebos, Drug Therapy, Combination, HIV Protease Inhibitors, Indinavir, Reverse Transcriptase Inhibitors, efavirenz
Brief summary
The purpose of this study is to see if it is safe and effective to add DMP 266 to an anti-HIV treatment program of indinavir and nucleoside reverse transcriptase inhibitors (NRTIs).
Detailed description
In this double-blind, placebo-controlled study, 300 patients are randomized to 1 or 2 reverse transcriptase inhibitors of their choice plus blinded therapy on Arm A or B as follows: Arm A: DMP 266 placebo plus indinavir. Arm B: DMP 266 plus indinavir. After 16 weeks, patients may switch the NRTI portion of their regimen if they meet a treatment failure criterion. After the completion of the 24-week period, patients have the option to continue on open-label DMP 266 and indinavir.
Interventions
DRUGIndinavir sulfate
DRUGEfavirenz
Sponsors
Dupont Merck
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
13 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Patients must have: * CD4+ cell count of at least 50 cells/mm3. * HIV RNA level of at least 10,000 copies/ml by reverse transcriptase polymerase chain reaction (RT-PCR, Amplicor test kit) at screening. * Signed, informed consent from parent or legal guardian for patients less than 18 years of age.
Exclusion criteria
Prior Medication: Excluded: * DMP 266. * Other nonnucleoside reverse transcriptase inhibitors. Required: One or two NRTIs (except ZDV and d4T in combination) for a minimum of 8 weeks, within 12 weeks prior to screening.
Countries
Canada, Puerto Rico, United States
Outcome results
None listed