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

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsored by:	Pharmacia and Upjohn
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002400

Purpose

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:	Treatment, Safety Study
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:

MedlinePlus related topics: AIDS

Drug Information available for: Zidovudine Lamivudine Delavirdine Delavirdine mesylate Indinavir Indinavir Sulfate

U.S. FDA Resources

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

Estimated Enrollment:

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.

Eligibility

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

Criteria

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.

Contacts and Locations

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

Locations

United States, New Jersey
Pharmacia & Upjohn
Peapack, New Jersey, United States, 07977

Sponsors and Collaborators

Pharmacia and Upjohn

More Information

No publications provided

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

Keywords provided by NIH AIDS Clinical Trials Information Service:

HIV-1
Drug Therapy, Combination
Zidovudine
HIV Protease Inhibitors
Lamivudine

Indinavir
RNA, Viral
Delavirdine
Reverse Transcriptase Inhibitors

Study placed in the following topic categories:

Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
HIV Protease Inhibitors
Anti-HIV Agents
Indinavir
Acquired Immunodeficiency Syndrome
Zidovudine
Lamivudine
Delavirdine

Antiviral Agents
Immunologic Deficiency Syndromes
Protease Inhibitors
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Indinavir
Molecular Mechanisms of Pharmacological Action
Zidovudine
Lamivudine
Delavirdine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on September 01, 2009