Skip to main content
OpenTrials
Completed

NCT Number: NCT00002401

A Study of Delavirdine Used Together With Other Anti-HIV Drugs in HIV-Infected Patients

The purpose of this study is to see if it is safe and effective to give delavirdine (DLV) in combination with two or three other drugs to HIV-infected patients. The drugs to be used in combination with DLV are zidovudine (ZDV), indinavir (IDV), and lamivudine (3TC).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

14 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 open-label pilot study, patients are randomized to 1of the following 4 arms for 24 weeks:

Arm 1 (40 patients): DLV plus ZDV plus IDV. Arm 2 (40 patients): DLV plus IDV plus 3TC*. Arm 3 (40 patients): DLV plus ZDV plus IDV plus 3TC. Arm 4 (40 patients): ZDV plus IDV plus 3TC.

  • Dose determined by body weight. Patients may opt to continue on study for 24 additional weeks at the discretion of the investigator.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Prior Medication:

Allowed:

Less than 1 month prior treatment with zidovudine.

Exclusion criteria

Prior Medication:

Excluded:

  • Prior indinavir.
  • Prior lamivudine.
  • Prior protease inhibitors.
  • Prior non-nucleoside reverse transcriptase inhibitors.
  • 1 month or more prior zidovudine.
  • HIV-1 positive.
  • CD4 coun tis above 50.
  • HIV-1 RNA levels greater than 20,000.

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 (DLV, Rescriptor) in Triple and Quadruple Combinations With Zidovudine (ZDV), Indinavir (IDV), and Lamivudine (3TC) 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.

Related clinical trials

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