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

This study has been completed.

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

Sponsor:	Pharmacia and Upjohn
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002401

Purpose

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).

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

160

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	14 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

1. HIV-1 positive.
CD4 coun tis above 50.
HIV-1 RNA levels greater than 20,000.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002401

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:	228F, 0074
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002401 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

HIV-1
Zidovudine
HIV Protease Inhibitors
Lamivudine
Indinavir

RNA, Viral
Delavirdine
Reverse Transcriptase Inhibitors
Viral Load

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 November 30, 2009