Search / Trial NCT00002155

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

Launched by MERCK SHARP & DOHME LLC · Aug 30, 2001

Trial Information

Current as of November 03, 2024

Completed

Keywords

Drug Therapy, Combination Acquired Immunodeficiency Syndrome Antiviral Agents Zidovudine Hiv Protease Inhibitors Lamivudine Indinavir

ClinConnect Summary

AZT-experienced patients are randomized to receive MK-639/AZT/3TC or MK-639 alone or AZT/3TC. Additionally, patients who have received \< 6 months of AZT or who are intolerant but received prior 3TC or who require concomitant rifampin therapy may receive open-label MK-639.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • 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.
  • Exclusion Criteria
  • 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.

About Merck Sharp & Dohme Llc

Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., is a leading global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines that address unmet medical needs. With a strong focus on research and development, Merck Sharp & Dohme leverages advanced science and technology to enhance patient outcomes across various therapeutic areas, including oncology, infectious diseases, and cardiovascular health. Committed to ethical practices and regulatory compliance, the company actively engages in clinical trials to advance medical knowledge and improve health care for patients worldwide.

Locations

Whitehouse Station, New Jersey, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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