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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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002155
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1996
  Purpose

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.


Condition Intervention
HIV Infections
Drug: Indinavir sulfate
Drug: Lamivudine
Drug: Zidovudine

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 600
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002155

Locations
United States, New Jersey
Merck & Co Inc
Whitehouse Station, New Jersey, United States, 088890100
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00002155     History of Changes
Other Study ID Numbers: 246E, 039
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
Antiviral Agents
Zidovudine
HIV Protease Inhibitors
Lamivudine
Indinavir

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Antiviral Agents
Indinavir
Lamivudine
Zidovudine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014