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

This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: January 1999
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.

Condition Intervention
HIV Infections
Drug: Indinavir sulfate
Drug: Delavirdine mesylate
Drug: Lamivudine
Drug: Zidovudine

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 45
Detailed Description:
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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria

Patients must have:

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

Prior Medication:


Less than 1 month prior treatment with zidovudine.

Exclusion Criteria

Prior Medication:


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

Prior Treatment:


  • Lamivudine.
  • Protease inhibitors.
  • Non-nucleoside reverse transcriptase inhibitors.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002400

United States, New Jersey
Pharmacia & Upjohn
Peapack, New Jersey, United States, 07977
Sponsors and Collaborators
Pharmacia and Upjohn
  More Information

ClinicalTrials.gov Identifier: NCT00002400     History of Changes
Other Study ID Numbers: 228C  0063 
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
HIV Protease Inhibitors
RNA, Viral
Reverse Transcriptase Inhibitors

Additional relevant MeSH terms:
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on May 22, 2016