Safety and Effectiveness of Giving Combinations of Three or Four Anti-HIV Drugs to HIV-Infected Patients - Full Text View

Purpose

The purpose of this study is to see if it is safe and effective to give combinations of three or four anti-HIV drugs to HIV-infected patients. The drugs used in this study are delavirdine (DLV), nelfinavir (NLF), didanosine (ddI), and stavudine (d4T).

Condition	Intervention
HIV Infections	Drug: Nelfinavir mesylate Drug: Delavirdine mesylate Drug: Stavudine Drug: Didanosine

MedlinePlus related topics:

AIDS AIDS Medicines

ChemIDplus related topics:

Delavirdine mesylate Delavirdine Didanosine Stavudine Nelfinavir Nelfinavir Mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Safety Study

Official Title:	An Open-Label Randomized Study of Delavirdine Mesylate (DLV, Rescriptor) Plus Nelfinavir (NFV), Didanosine (ddI), and Stavudine (d4T) in Triple and Quadruple Treatment Regimens in HIV-1 Infected Individuals

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

Estimated Enrollment:

160

Detailed Description:

This is a multicenter, open-label study. Patients are stratified by HIV-1 RNA levels (20,000 to 200,000 copies/ml and greater than 200,000 copies/ml). Patients are equally randomized to one of four groups and receive antiretroviral therapy for 24 weeks. Group 1 receives delavirdine (DLV) plus nelfinavir (NFV) plus stavudine (d4T). Group 2 receives DLV plus NFV plus didanosine (ddI). Group 3 receives NFV plus d4T plus ddI. Group 4 receives DLV plus NFV plus d4T plus ddI. Patients are evaluated for drug safety and viral burden. Patients may opt to continue on the study for 24 additional weeks, at the discretion of the investigator.

Eligibility

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

Criteria

Inclusion Criteria

You may be eligible for this study if you:

Are at least 18 years old.
Are HIV-positive.
Have a CD4 count of at least 50 cells/mm3.
Have a viral load of at least 20,000 copies/ml.

Exclusion Criteria

You will not be eligible for this study if you:

Have taken d4T.
Have taken protease inhibitors, including NFV.
Have taken nonnucleoside reverse transcriptase inhibitors.
Have taken ddI for 1 month or more.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002211

Locations


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

Sponsors and Collaborators

Pharmacia and Upjohn

More Information

Study ID Numbers:	228E, 0073
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002211
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

HIV-1

Didanosine

Stavudine

HIV Protease Inhibitors

RNA, Viral

Delavirdine

Reverse Transcriptase Inhibitors

Viral Load

Nelfinavir

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

Stavudine

Didanosine

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Delavirdine

Nelfinavir

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 September 16, 2008

Sponsored by:	Pharmacia and Upjohn
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002211