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A Study on the Safety and Effectiveness of L-756423 Plus Indinavir in HIV-Positive Patients Who Have Previously Taken Indinavir

NCT ID: NCT00002452

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

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to see if L-756423, an anti-HIV drug, is safe to give with indinavir and if it works well at lowering the level of HIV in the blood (viral load).

Detailed Description

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All patients receive L-756423 plus indinavir plus two licensed nucleoside reverse transcriptase inhibitors (NRTIs), at least one to which the patient is naive. Patients remain on the drug regimen for 12 weeks (with possible extension to 16 weeks). Patients are evaluated with physical examinations and laboratory tests for blood and urine at Weeks 1, 2, 4, 6, 8, and 12 and two weeks post study. Plasma viral RNA is measured at Weeks 1, 2, 4, 6, 8, and 12. CD4 cell counts are measured at Weeks 2,4,8, and 12.

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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L-756423

Intervention Type DRUG

Indinavir sulfate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive.
* Are at least 18 years old.
* Have a viral load of at least 1,000 copies/ml.
* Have a CD4 cell count of at least 100 cells/mm3.
* Have experienced treatment failure (your viral load increased significantly) within 24 weeks of study entry while taking indinavir.

Exclusion Criteria

You will not be eligible for this study if you:

* Are taking nonnucleoside reverse transcriptase inhibitors (NNRTIs).
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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Univ of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Georgetown Univ

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

Site Status

AIDS Research Consortium of Atlanta

Atlanta, Georgia, United States

Site Status

Hawaii AIDS Clinical Trial Unit

Honolulu, Hawaii, United States

Site Status

The CORE Ctr

Chicago, Illinois, United States

Site Status

Cornell Clinical Trials Unit - Chelsea Clinic

New York, New York, United States

Site Status

Pittsburgh Treatment Ctr / Univ of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Vanderbilt Univ Med Ctr

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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008-00

Identifier Type: -

Identifier Source: secondary_id

300A

Identifier Type: -

Identifier Source: org_study_id