NCT Number: NCT00002410
A Study of Three Different Anti-HIV Drug Combinations in HIV-Infected Patients
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.
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Notify MeKey information
Conditions
Age range
13 year–60 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Javier O Morales Ramirez, San Juan, Puerto Rico
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Lamivudine
DrugZidovudine
DrugSponsors and collaborators
Lead sponsor
Dupont Merck
Industry
Registry information
Official study title
A Phase III, Multicenter, Randomized, Open-Label Study to Compare Antiretroviral Activity and Tolerability of Three Different Combination Regimens (DMP 266 + Indinavir, DMP 266 + Zidovudine + Lamivudine, Indinavir + Zidovudine + Lamivudine) in HIV-Infected Patients
Important dates
- First posted
- Aug 31, 2001
- Registry last updated
- Jun 24, 2005
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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