Safety and Effectiveness of Giving Combinations of Three or Four Anti-HIV Drugs to 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:	NCT00002211

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

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS AIDS Medicines

Drug Information available for: Didanosine Delavirdine Delavirdine mesylate Nelfinavir Nelfinavir Mesylate Stavudine

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	228E, 0073
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002211 History of Changes
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

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Stavudine
Molecular Mechanisms of Pharmacological Action
Delavirdine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Nelfinavir
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
Didanosine
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on February 08, 2010