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

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

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 (DLV, Rescriptor) in Triple and Quadruple Combinations With Zidovudine (ZDV), Indinavir (IDV), and Lamivudine (3TC) in HIV-1 Infected Individuals

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

Study ID Numbers:	228F, 0074
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002401
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

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:	NCT00002401