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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:
ClinicalTrials.gov Identifier:
NCT00002155
First Posted: August 31, 2001
Last Update Posted: March 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  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: Masking: Double
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: March 17, 2014
Last Verified: June 1996

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:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lamivudine
Zidovudine
Indinavir
Antiviral Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-Infective Agents
Anti-HIV Agents
Antimetabolites
HIV Protease Inhibitors
Protease Inhibitors