A Comparison of Two Dose Levels of Indinavir Combined With Two Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) in HIV-Infected Patients

NCT ID: NCT00002406

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

PHASE3

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to determine if two dose levels of indinavir combined with two nucleoside analogue reverse transcriptase inhibitors (NRTIs) have the same effect on plasma viral load (level of HIV in the blood).

Detailed Description

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In this open-label study 350 seropositive HIV-1 men and women are first stratified according to baseline plasma viral RNA (less than 400 copies/mL vs negative plasma viral RNA result) then randomized into one of two arms:

Arm 1: Indinavir (800 mg, q8h) plus two pre-existing NRTIs. Arm 2: Indinavir (1,200 mg, q12h) plus two pre-existing NRTIs. Plasma viral RNA will be measured every 4 weeks for the duration of the 24-week study.

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Indinavir sulfate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients must have:

* Documented HIV-1 seropositive status.
* CD4 count greater than 100 cells/mm3.
* Parental consent for patients under 18.
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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1917 Research Clinic

Birmingham, Alabama, United States

Site Status

Kaiser Permanente / Infectious Disease

Los Angeles, California, United States

Site Status

Tower ID Med Associates

Los Angeles, California, United States

Site Status

Ctr for AIDS Research / Education and Service (CARES)

Sacramento, California, United States

Site Status

San Francisco Gen Hosp / UCSF AIDS Program

San Francisco, California, United States

Site Status

HIV Clinical Research

Fort Lauderdale, Florida, United States

Site Status

Univ of Miami School of Medicine

Miami, Florida, United States

Site Status

AIDS Research Consortium of Atlanta

Atlanta, Georgia, United States

Site Status

Ponce de Leon Ctr

Atlanta, Georgia, United States

Site Status

Northwestern Univ Med School

Chicago, Illinois, United States

Site Status

Rush Presbyterian St Lukes Med Ctr

Chicago, Illinois, United States

Site Status

Natl Naval Med Ctr / Special Immunology Clinic

Bethesda, Maryland, United States

Site Status

Brigham and Women's Hosp

Boston, Massachusetts, United States

Site Status

Boston Med Ctr / Clinical Research Office

Boston, Massachusetts, United States

Site Status

Univ Health Ctr 7D

Detroit, Michigan, United States

Site Status

Kansas City Free Health Clinic

Kansas City, Missouri, United States

Site Status

Education & Research Building

Camden, New Jersey, United States

Site Status

Garden State Infectious Diseases / E I P Kennedy Health Sys

Voorhees Township, New Jersey, United States

Site Status

Albany Med College / Div of HIV Medicine

Albany, New York, United States

Site Status

SUNY / Health Science Ctr at Brooklyn

Brooklyn, New York, United States

Site Status

New York Hosp of Queens / AIDS Ctr

Flushing, New York, United States

Site Status

CRIA

New York, New York, United States

Site Status

St Vincents Hosp and Med Ctr / Div of HIV Med

New York, New York, United States

Site Status

Anderson Clinical Research

New York, New York, United States

Site Status

Akron City Hospital

Akron, Ohio, United States

Site Status

Thomas Jefferson Univ

Philadelphia, Pennsylvania, United States

Site Status

Anderson Clinical Research

Pittsburgh, Pennsylvania, United States

Site Status

Houston Clinical Research Network / Southhampton Med Group

Houston, Texas, United States

Site Status

Univ of Utah School Of Medicine / Div of Infec Disease

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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MK-0639

Identifier Type: -

Identifier Source: secondary_id

246P

Identifier Type: -

Identifier Source: org_study_id