Skip to main content
OpenTrials
Completed

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.

Completed

Looking for future studies?

Notify Me

Key information

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

Loading trial locations.

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

Indinavir sulfate

Drug

Lamivudine

Drug

Zidovudine

Drug

Sponsors 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.

Published trials that share one or more normalized conditions with this study.