Skip to main content
OpenTrials
Completed

NCT Number: NCT00002400

A Study of Two Anti-HIV Drug Combinations in HIV-Infected Patients

The purpose of this study is to compare the safety and effectiveness of giving HIV-infected patients delavirdine (DLV) plus zidovudine (ZDV) plus 2 doses of indinavir (IDV) or ZDV plus IDV plus lamivudine (3TC). This study also examines how the body processes DLV when it is given in combination with other drugs.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pharmacia & Upjohn

Peapack, New Jersey, 07977, United States

About this study

In this multicenter, open-label study, 45 HIV-1-positive patients receive either combination drug therapy with delavirdine (DLV), zidovudine (ZDV), and indinavir (IDV) or combination drug therapy with ZDV, lamivudine (3TC), and IDV. NOTE: Patients are treated for 24 weeks and may opt to continue on study for 24 additional weeks, if HIV-1 RNA is less than 5,000 copies/ml or at the investigator's discretion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients must have:

  • HIV-1 positive.
  • CD4 count above 50.
  • HIV-1 RNA greater than 20,000.

Prior Medication:

Allowed:

Less than 1 month prior treatment with zidovudine.

Exclusion criteria

Prior Medication:

Excluded:

  • Prior 3TC, protease inhibitors, or non-nucleoside reverse transcriptase inhibitors.
  • Prior ZDV of greater than 1 month total duration.

Prior Treatment:

Excluded:

  • Lamivudine.
  • Protease inhibitors.
  • Non-nucleoside reverse transcriptase inhibitors.

Treatment and study plan

Indinavir sulfate

Drug

Delavirdine mesylate

Drug

Lamivudine

Drug

Zidovudine

Drug

Sponsors and collaborators

Lead sponsor

Pharmacia and Upjohn

Industry

Registry information

Official study title

An Open-Label Randomized Study of Delavirdine Mesylate (Rescriptor) in Combination With Zidovudine (Retrovir) and Two Doses of Indinavir (Crixivan) Versus Zidovudine, Lamivudine (Epivir), and Indinavir in HIV-1-Infected Individuals

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.