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A Study of Indinavir Sulfate Given Together With Stavudine to HIV-Positive Patients

This study has been completed.

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

MedlinePlus related topics:   AIDS   

Drug Information available for:   Indinavir    Indinavir Sulfate    Stavudine   

U.S. FDA Resources

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)

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


Study ID Numbers:   246D, 37
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002354
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:
Virus Diseases
Sexually Transmitted Diseases, Viral
Stavudine
Indinavir
HIV Seropositivity
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 03, 2008




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