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

NCT ID: NCT00002430

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Indinavir sulfate

Intervention Type DRUG

Nelfinavir mesylate

Intervention Type DRUG

Lamivudine

Intervention Type DRUG

Stavudine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Locations

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Univ of Alabama School of Med

Montgomery, Alabama, United States

Site Status

Ocean View Internal Medicine

Long Beach, California, United States

Site Status

AIDS Healthcare Foundation

Los Angeles, California, United States

Site Status

Tower ID Med Associates

Los Angeles, California, United States

Site Status

Oasis Clinic / King Drew Med Ctr

Los Angeles, California, United States

Site Status

Robert Scott MD

Oakland, California, United States

Site Status

AIDS Community Research Consortium

Redwood City, California, United States

Site Status

Saint Francis Mem Hosp / HIV Care Unit

San Francisco, California, United States

Site Status

Pacific Horizons Med Group

San Francisco, California, United States

Site Status

Kaiser Foundation Hospital

San Francisco, California, United States

Site Status

Harbor - UCLA Med Ctr

Torrance, California, United States

Site Status

Denver Public Health Dept

Denver, Colorado, United States

Site Status

Blick Med Associates

Stamford, Connecticut, United States

Site Status

Physicans Home Service

Washington D.C., District of Columbia, United States

Site Status

IDC Research Initiative

Altamonte Springs, Florida, United States

Site Status

Univ of Miami School of Medicine

Miami, Florida, United States

Site Status

Hillsborough County Health Dept

Tampa, Florida, United States

Site Status

Emory Univ

Atlanta, Georgia, United States

Site Status

Harold Katner MD

Macon, Georgia, United States

Site Status

Thomas Coffman MD

Boise, Idaho, United States

Site Status

Chicago Ctr for Clinical Research

Chicago, Illinois, United States

Site Status

Northwestern Univ Med Ctr

Chicago, Illinois, United States

Site Status

Univ of Illinois

Chicago, Illinois, United States

Site Status

Kentucky Clinical Research

Lexington, Kentucky, United States

Site Status

Louisiana State Univ Med Ctr / Tulane Med School

New Orleans, Louisiana, United States

Site Status

AIDS Consultation Service / Maine Med Ctr

Portland, Maine, United States

Site Status

Institute of Human Virology

Baltimore, Maryland, United States

Site Status

JSI Research and Training Institute

Boston, Massachusetts, United States

Site Status

Education & Research Building

Camden, New Jersey, United States

Site Status

NJCRI

Newark, New Jersey, United States

Site Status

Infectious Disease Specialists of NJ

Union, New Jersey, United States

Site Status

Brookdale Univ Hosp and Med Ctr

Brooklyn, New York, United States

Site Status

Liberty Med Group

New York, New York, United States

Site Status

James Jones MD

New York, New York, United States

Site Status

Mount Sinai Med Ctr

New York, New York, United States

Site Status

Community Health Network

Rochester, New York, United States

Site Status

Wake Forest Univ School of Medicine

Winston-Salem, North Carolina, United States

Site Status

Associates in Med and Mental Health

Tulsa, Oklahoma, United States

Site Status

The Research and Education Group

Portland, Oregon, United States

Site Status

Fanno Creek Clinic

Portland, Oregon, United States

Site Status

Anderson Clinical Research / Inc

Pittsburgh, Pennsylvania, United States

Site Status

Burnside Clinic

Columbia, South Carolina, United States

Site Status

Vanderbilt Univ Med Ctr

Nashville, Tennessee, United States

Site Status

Oak Lawn Physicians Group

Dallas, Texas, United States

Site Status

Univ TX Galveston Med Branch

Galveston, Texas, United States

Site Status

Infections Ltd / Physicians Med Ctr

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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079-02

Identifier Type: -

Identifier Source: secondary_id

CRX454

Identifier Type: -

Identifier Source: secondary_id

246R

Identifier Type: -

Identifier Source: org_study_id