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A Study of Indinavir Sulfate Given Together With Stavudine to HIV-Positive Patients
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsored by: Merck
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002354
  Purpose

The purpose of this study is to see if it is safe and effective to give indinavir sulfate plus stavudine to HIV-infected patients who have already been treated with zidovudine.


Condition Intervention
HIV Infections
Drug: Indinavir sulfate
Drug: Stavudine

Study Type: Interventional
Study Design: Treatment, Double-Blind, Safety Study
Official Title: One Year Study in HIV-1 Seropositive, AZT-Experienced Patients to Evaluate the Safety and Efficacy of MK-639 Administered Concomitantly With Stavudine (d4T)

Resource links provided by NLM:


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

Estimated Enrollment: 540
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Prophylaxis with aerosolized pentamidine, topical antifungals, TMP / SMX, dapsone, or isoniazid.

Patients must have:

  • HIV infection.
  • CD4 count 50 - 500 cells/mm3.
  • Prior AZT use for more than 6 months OR documented intolerance to AZT with more than 6 months use of another anti-HIV therapy other than d4T or any protease inhibitor.
  • No active opportunistic infection or visceral Kaposi's sarcoma.

NOTE:

  • Patients with hemophilia may be enrolled at discretion of investigator.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Symptomatic neuropathy.
  • Acute hepatitis.

Concurrent Medication:

Excluded:

  • Antiretrovirals other than specified in protocol.
  • Chronic therapy for an active opportunistic infection.
  • Immunosuppressive therapy.

Prior Medication:

Excluded:

  • Any prior protease inhibitor or d4T.
  • Any nucleoside analogs within 2 weeks prior to study entry.
  • Investigational agents or immunomodulators within 30 days prior to study entry.

Required:

  • More than 6 months of prior AZT unless intolerant, in which case more than 6 months of another anti-HIV therapy (other than protease inhibitors or d4T).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002354

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

No publications provided

Study ID Numbers: 246D, 37
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002354     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Stavudine
HIV Protease Inhibitors
Indinavir

Study placed in the following topic categories:
Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
HIV Protease Inhibitors
Anti-HIV Agents
Stavudine
Indinavir
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Protease Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Seropositivity
HIV Infections
Sexually Transmitted Diseases
Retroviridae Infections

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

ClinicalTrials.gov processed this record on September 02, 2009