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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002208
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: February 2003

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002208 on ClinicalTrials.gov Archive Site
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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
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

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.

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).

Interventional
Phase 3
Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
HIV Infections
  • Drug: Indinavir sulfate
  • Drug: Lamivudine
  • Drug: Stavudine
  • Drug: Zidovudine
Not Provided
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. 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
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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.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002208
246M, 069-00
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Merck Sharp & Dohme Corp.
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NIH AIDS Clinical Trials Information Service
February 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP