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NCT00002208 Clinical Trial

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

HIV Infections Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00002208
Other study ID # 246M
Secondary ID 069-00
Status Completed
Phase Phase 3
First received November 2, 1999
Last updated June 23, 2005

Study information
Verified date February 2003
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Indinavir sulfate

• Lamivudine

• Stavudine

• Zidovudine

Locations
Country Name City State
United States AIDS Research Consortium of Atlanta Atlanta Georgia
United States Johns Hopkins Hosp Baltimore Maryland
United States Univ of Alabama at Birmingham Birmingham Alabama
United States Cook County Hosp Chicago Illinois
United States LAC/USC Med Ctr Los Angeles California
United States Vanderbilt Univ Med Ctr Nashville Tennessee
United States Allegheny Univ Hosp Philadelphia Pennsylvania
United States Pittsburgh Treatment Ctr / Univ of Pittsburgh Pittsburgh Pennsylvania
United States Brown Univ / Miriam Hosp Providence Rhode Island
United States Kaiser Med Ctr San Francisco California
United States Univ of Washington / AIDS Clinical Trial Unit Seattle Washington
United States Washington Univ St. Louis Missouri
United States Univ Hosp / SUNY at Stony Brook / AIDS TMT Unit Stony Brook New York
United States Georgetown Univ Med Ctr Washington District of Columbia
United States Wilmington Hosp / Med Ctr of Delaware Wilmington Delaware

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

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