A Study of Three Different Anti-HIV Drug Combinations in HIV-Infected Patients (NCT00002410) | Clinical Trial Compass
CompletedPhase 3
A Study of Three Different Anti-HIV Drug Combinations in HIV-Infected Patients
United States
Plain-language 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.
Who can participate
Age range13 Years – 60 Years
SexALL
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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.