HIV Infections
Conditions
Keywords
HIV-1, Drug Therapy, Combination, Zidovudine, Drug Resistance, Microbial, HIV Protease Inhibitors, Lamivudine, Indinavir, Genotype, Reverse Transcriptase Inhibitors, efavirenz
Brief summary
The purpose of this study is to compare the safety and effectiveness of three anti-HIV drug combinations. The three combinations are: (1) efavirenz (DMP 266) plus indinavir; (2) DMP 266 plus zidovudine (ZDV) plus lamivudine (3TC); and (3) indinavir plus ZDV plus 3TC. This study also examines the resistance HIV may have to these drugs and if these drugs are effective over a long period of time.
Interventions
DRUGIndinavir sulfate
DRUGLamivudine
DRUGZidovudine
Sponsors
Dupont Merck
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
13 Years to 60 Years
Healthy volunteers
No
Exclusion criteria
Concurrent Medication: Excluded: * Terfenadine, astemizole, cisapride, triazolam, or midazolam (competition for the enzyme cytochrome P-450 3A4 \[CYP3A4\] by indinavir could result in inhibition of metabolic breakdown of these drugs and create the potential for serious and/or life threatening events \[i.e., cardiac arrhythmia, prolonged sedation\]). * Rifampin or rifabutin (prohibited because of potential drug interaction with indinavir). * Ketoconazole, itraconazole, and clarithromycin. * Concomitant systemic therapy for acute opportunistic infection or malignancy. Excluded: Life expectancy less than 12 months. Prior Medication: Excluded: * Prior treatment with efavirenz, 3TC, an NNRTI, or an HIV protease inhibitor. * Prior antiretroviral agent within 14 days of initiating study treatment. * Prior treatment (within 30 days of initiating study treatment) with any other experimental drug for any indication. Patients must: * Have a diagnosis of HIV infection. * Have CD4 counts greater than or equal to 50 cell/mm3. * Have a life expectancy greater than or equal to 12 months. * Be post-pubescent.
Countries
Puerto Rico, United States
Outcome results
None listed