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A Study to Compare the Safety and Effectiveness of Indinavir Combined With Stavudine and Lamivudine

NCT ID: NCT00002424

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

SUSPENDED

Clinical Phase

PHASE2

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Brief Summary

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This study will see how safe and effective against HIV the drugs L-756423 plus indinavir (IDV) are compared to just IDV when taken with stavudine (d4T) and lamivudine (3TC). The study will also see whether taking 1 large dose of L-756423/IDV once a day is as safe and effective as taking 2 smaller doses twice a day.

Detailed Description

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Patients are randomized to 1 of 4 treatment arms. In Group 1, patients receive a dose of L-756423/IDV once daily plus IDV placebo. In Group 3, patients receive a lower dose of L-756423/IDV twice daily (with the daily dosage equaling that of Group 1) plus IDV placebo. In Groups 2 and 4, patients receive equal dosages of IDV plus L-756423/IDV placebo. In all 4 groups L-756423 and IDV are blinded to the investigator and patient. All groups receive open-label d4T and 3TC. Patients routinely undergo a physical exam and have blood and urine tests to ensure the drugs' safety and tolerability, which will be evaluated by tabulation of adverse events and clinical assessment of laboratory data. In addition, CD4+ T cell and plasma viral RNA levels are measured to quantify the drugs' antiretroviral activity.

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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L-756423

Intervention Type DRUG

Indinavir sulfate

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 trial if you:

* Have HIV infection.
* Have levels of CD4 cells of 100 cells/mm3 or greater.
* Have a viral load of 10,000 copies/ml or greater.
* Are 18 years of age or older.

Exclusion Criteria

You may not be eligible for this trial if you:

* Have ever taken anti-HIV drugs.
Minimum Eligible Age

18 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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UCLA School of Medicine / Ctr for Research and Education

Los Angeles, California, United States

Site Status

Georgetown Univ Med Ctr

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

Site Status

ViRx / Dupont Circle Physicians Group

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

Site Status

Associates in Research

Fort Myers, Florida, United States

Site Status

Univ of Miami School of Medicine

Miami, Florida, United States

Site Status

Grady Mem Hosp

Atlanta, Georgia, United States

Site Status

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, United States

Site Status

The CORE Ctr

Chicago, Illinois, United States

Site Status

Univ of Kentucky Med Ctr

Lexington, Kentucky, United States

Site Status

Univ of Kentucky

Lexington, Kentucky, United States

Site Status

Beth Israel Deaconess Med Ctr

Boston, Massachusetts, United States

Site Status

Henry Ford Hosp

Detroit, Michigan, United States

Site Status

NYU Med Ctr / C & D Building

New York, New York, United States

Site Status

Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ

New York, New York, United States

Site Status

SUNY at Stony Brook / Div of Infectious Disease

Stony Brook, New York, United States

Site Status

The Miriam Hosp

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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009-01

Identifier Type: -

Identifier Source: secondary_id

009-00

Identifier Type: -

Identifier Source: secondary_id

300B

Identifier Type: -

Identifier Source: org_study_id