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A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 Mg q 8 h Versus 1,200 Mg q 12 h in Combination With Zidovudine and 3TC

NCT ID: NCT00002208

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

400 participants

Study Classification

INTERVENTIONAL

Brief Summary

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To demonstrate that the antiviral activity and safety/tolerability of a test regimen of indinavir is equivalent to that of a control regimen of indinavir when each is coadministered with zidovudine (ZDV) (or stavudine, d4T) and lamivudine (3TC) for 24 weeks to protease inhibitor- and 3TC-naive HIV-1-seropositive patients. To characterize the steady-state pharmacokinetic profiles of indinavir, ZDV (or d4T), and 3TC in the presence of each other, for both the control and test regimen groups.

Detailed Description

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Patients are randomized to 1 of 2 arms:

Arm A: Indinavir plus ZDV plus 3TC. Arm B: Indinavir (test dose) plus ZDV plus 3TC. NOTE: d4T may be substituted for zidovudine for toxicity management. Patients are stratified based on prior use of nucleoside analogs (naive vs experienced to ZDV, dideoxyinosine \[ddI\], dideoxycytidine \[ddC\], and d4T) and screening viral RNA results (lower than 50,000 copies/mL vs more than 50,000 copies/mL).

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

Lamivudine

Intervention Type DRUG

Stavudine

Intervention Type DRUG

Zidovudine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients must have:

* HIV-1 seropositive status.
* CD4 count greater than 100 cells/mm3.
* Viral RNA above 10,000 copies/mL.
* Consent from parent or guardian if less than 18 years of age.

Exclusion Criteria

Prior Medication:

Excluded:

* Prior therapy with protease inhibitors.
* Prior therapy with 3TC.
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 at Birmingham

Birmingham, Alabama, United States

Site Status

LAC/USC Med Ctr

Los Angeles, California, United States

Site Status

Kaiser Med Ctr

San Francisco, California, United States

Site Status

Wilmington Hosp / Med Ctr of Delaware

Wilmington, Delaware, United States

Site Status

Georgetown Univ Med Ctr

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

Site Status

AIDS Research Consortium of Atlanta

Atlanta, Georgia, United States

Site Status

Cook County Hosp

Chicago, Illinois, United States

Site Status

Johns Hopkins Hosp

Baltimore, Maryland, United States

Site Status

Washington Univ

St Louis, Missouri, United States

Site Status

Univ Hosp / SUNY at Stony Brook / AIDS TMT Unit

Stony Brook, New York, United States

Site Status

Allegheny Univ Hosp

Philadelphia, Pennsylvania, United States

Site Status

Pittsburgh Treatment Ctr / Univ of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Brown Univ / Miriam Hosp

Providence, Rhode Island, United States

Site Status

Vanderbilt Univ Med Ctr

Nashville, Tennessee, United States

Site Status

Univ of Washington / AIDS Clinical Trial Unit

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Haas DW, Arathoon E, Thompson MA, de Jesus Pedro R, Gallant JE, Uip DE, Currier J, Noriega LM, Lewi DS, Uribe P, Benetucci L, Cahn P, Paar D, White AC Jr, Collier AC, Ramirez-Ronda CH, Harvey C, Chung MO, Mehrotra D, Chodakewitz J, Nguyen BY; Protocol 054/069 Study Teams. Comparative studies of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine. AIDS. 2000 Sep 8;14(13):1973-8. doi: 10.1097/00002030-200009080-00013.

Reference Type BACKGROUND
PMID: 10997402 (View on PubMed)

Other Identifiers

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069-00

Identifier Type: -

Identifier Source: secondary_id

246M

Identifier Type: -

Identifier Source: org_study_id