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

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

MedlinePlus related topics:

AIDS

Drug Information available for:

Zidovudine Lamivudine Indinavir Indinavir Sulfate Delavirdine mesylate Delavirdine

U.S. FDA Resources

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

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.

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

Study ID Numbers:	228C, 0063
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002400
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:

Virus Diseases

Sexually Transmitted Diseases, Viral

Indinavir

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Lamivudine

Zidovudine

Delavirdine

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

HIV Protease Inhibitors

RNA Virus Infections

Anti-HIV Agents

Slow Virus Diseases

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Protease Inhibitors

Reverse Transcriptase Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 03, 2008

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