A Study to Compare the Effectiveness of Two Anti-HIV Drug Combinations

This study has been completed.

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

Sponsor:	Merck
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002430

Purpose

The purpose of this study is to compare two different anti-HIV drug combinations, one that contains nelfinavir (NFV) and one that does not. The best dosing schedule for indinavir (IDV) also will be studied.

Condition	Intervention
HIV Infections	Drug: Indinavir sulfate Drug: Nelfinavir mesylate Drug: Lamivudine Drug: Stavudine

Study Type:	Interventional
Study Design:	Treatment, Safety Study
Official Title:	A Multicenter, Open-Label, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate/d4T/3TC Versus Indinavir Sulfate/Nelfinavir Mesylate/d4T/3TC in HIV-Infected Individuals

Resource links provided by NLM:

MedlinePlus related topics: AIDS AIDS Medicines

Drug Information available for: Lamivudine Indinavir Indinavir Sulfate Nelfinavir Nelfinavir Mesylate Stavudine

U.S. FDA Resources

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

Estimated Enrollment:

220

Detailed Description:

Patients are stratified by screening plasma viral RNA results (50,000 copies/ml or below vs above 50,000 copies/ml) and randomized to 1 of 2 treatment arms. Group 1 receives IDV 3 times daily plus d4T/3TC twice daily. Group 2 receives IDV/NFV/d4T/3TC twice daily. Patients remain on study medications for 24 weeks and are seen at the clinic once every 4 weeks after entering the study. At each clinic visit, blood samples are taken to evaluate CD4 cell count and plasma HIV RNA levels.

Eligibility

Ages Eligible for Study:	16 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 HIV positive.
Have a viral load (level of HIV in your blood) of at least 10,000 copies/ml within 45 days of study entry.
Have a CD4 cell count of at least 100 cells/mm3 within 45 days of study entry.
Have a normal chest X-ray.
Have never taken protease inhibitors or 3TC.
Are 16 years of age or older.
Agree to practice sexual abstinence or use barrier methods of birth control (e.g., condoms).

Exclusion Criteria

You will not be eligible for this study if you:

Have an active opportunistic (AIDS-related) infection or cancer.
Have certain types of Kaposi's sarcoma.
Have hepatitis.
Have chronic diarrhea.
Have a history of certain medical conditions.
Are allergic to any of the study medications.
Are taking certain medications.
Are pregnant or breast-feeding.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002430

Show 46 Study Locations

Sponsors and Collaborators

Merck

More Information

No publications provided

Study ID Numbers:	246R, 079-02, CRX454
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002430 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Drug Therapy, Combination
HIV Protease Inhibitors
Lamivudine
Indinavir

Reverse Transcriptase Inhibitors
Anti-HIV Agents
Nelfinavir

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Stavudine
Slow Virus Diseases
Indinavir
Molecular Mechanisms of Pharmacological Action
Lamivudine
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
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 27, 2009