A Six-Month Safety and Antiviral Study in HIV-1 Seropositive, AZT-Experienced Patients With CD4 Counts Less Than or Equal to 50 Cells/mm3 to Evaluate MK-639 Alone Versus Zidovudine (AZT) and 3TC Versus the Combination of MK-639 With AZT/3TC

Completed · Not applicable

Conditions studied: HIV Infections

In brief

To compare effects on CD4 counts and serum viral RNA among HIV-seropositive, zidovudine (AZT)-experienced patients in three treatment arms: indinavir sulfate ( MK-639; Crixivan ) plus AZT plus lamivudine ( 3TC ) versus MK-639 alone versus AZT/3TC.

Key facts

Study ID

NCT00002155

Run by

Merck Sharp & Dohme LLC

People needed

600

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Allowed for all patients:
• Standard prophylaxis for opportunistic infections.
• Continuation of treatment for opportunistic infection.
• Allowed for open-label study patients:
• Rifampin.
• Patients must have:
• HIV positivity.
• CD4 count <= 50 cells/mm3.
• More than 6 months of prior AZT (blinded study only).
• NOTE:
• Patients on the open-label study must have AZT intolerance or have < 6 months of prior AZT.
• Prior Medication:
• Required for blinded study patients:
• > 6 months of prior AZT.
• Required for open-label study patients:
• < 6 months of prior AZT.
• Allowed for open-label study patients:
• Prior 3TC.

You may not qualify if…

• Concurrent Medication:
• Excluded in all patients:
• Immunosuppressants.
• Excluded in blinded study patients:
• AZT, ddI, ddC, or d4T.
• Rifampin.
• Excluded in open-label study patients:
• 3TC.
• Prior Medication:
• Excluded in all patients:
• Prior protease inhibitors.
• Investigational agents and immunomodulators within 30 days prior to study entry.
• Immunosuppressants within 2 weeks prior to study entry.
• Excluded in blinded study patients:
• Any prior 3TC.
• AZT, ddI, ddC, or d4T within 2 weeks prior to study entry.
• Excluded in open-label study patients:
• 3TC within 30 days prior to study entry.

Where it is running

• Merck & Co Inc — Whitehouse Station, New Jersey, United States

Full record on ClinicalTrials.gov

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