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

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002208

Run by

Merck Sharp & Dohme LLC

People needed

400

Last updated by the study team

2005-06-24

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Prior Medication:
• Excluded:
• Prior therapy with protease inhibitors.
• Prior therapy with 3TC.

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• LAC/USC Med Ctr — Los Angeles, California, United States
• Kaiser Med Ctr — San Francisco, California, United States
• Wilmington Hosp / Med Ctr of Delaware — Wilmington, Delaware, United States
• Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• Cook County Hosp — Chicago, Illinois, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States
• Washington Univ — St Louis, Missouri, United States
• Univ Hosp / SUNY at Stony Brook / AIDS TMT Unit — Stony Brook, New York, 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
• Vanderbilt Univ Med Ctr — Nashville, Tennessee, United States
• Univ of Washington / AIDS Clinical Trial Unit — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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