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

One Year Study in HIV-1 Seropositive, AZT-Experienced Patients to Evaluate the Safety and Efficacy of MK-639 Administered Concomitantly With Stavudine (d4T)

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Indinavir sulfate; Drug: Stavudine

• Study Type: Interventional
• Enrollment: 540
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Whitehouse Station, New Jersey, United States, 088890100
      • Merck & Co Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Masking: Double

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Registration Dates

• First Submitted: November 2, 1999
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Estimate): June 24, 2005
• Last Update Submitted That Met QC Criteria: June 23, 2005
• Last Verified: January 1, 1996

More Information

Terms related to this study

• Keywords: Drug Therapy, Combination; Stavudine; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; HIV Protease Inhibitors; Indinavir
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Antimetabolites; Protease Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Stavudine; Indinavir
• Other Study ID Numbers: 246D; 37