The Safety and Effectiveness of Indinavir Sulfate Plus Efavirenz

A Multicenter, Open, Randomized, Forty-Eight-Week, Pilot Study to Evaluate the Activity, Safety, and Pharmacokinetics of Indinavir Sulfate, 1200 Mg q 12h and DMP 266, 300 Mg q 12h Versus Indinavir Sulfate, 1000 Mg q 8h and DMP 266, 600 Mg q.h.s.

To estimate the differences in parameters of antiviral activity and safety between a control regimen of indinavir in combination with DMP 266 and an experimental regimen of higher-dose indinavir in combination with lower-dose DMP 266 after sixteen weeks of dosing, in protease inhibitor- and non-nucleoside reverse transcriptase inhibitor-naive, HIV-1 seropositive patients.

It is hypothesized that after 16 weeks of randomized treatment with either the control or experimental regimen that:

1. The observed proportion of patients with serum viral RNA < 400 copies/ml in the experimental and control regimen will be similar and will continue to be so after 48 weeks.
2. The safety profiles of the two groups will be similar, judged by the incidence of serious, drug-related adverse experiences and the incidence of events of specific interest (e.g., nephrolithiasis, hyperbilirubinemia, nausea/vomiting, rash, and CNS-related symptoms) and will continue to be so after 48 weeks.
3. The two groups will be similar with respect to changes from baseline in serum viral RNA and CD4 counts and will continue to be so after 48 weeks.

Study Overview

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

Detailed Description

It is hypothesized that after 16 weeks of randomized treatment with either the control or experimental regimen that:

1. The observed proportion of patients with serum viral RNA < 400 copies/ml in the experimental and control regimen will be similar and will continue to be so after 48 weeks.
2. The safety profiles of the two groups will be similar, judged by the incidence of serious, drug-related adverse experiences and the incidence of events of specific interest (e.g., nephrolithiasis, hyperbilirubinemia, nausea/vomiting, rash, and CNS-related symptoms) and will continue to be so after 48 weeks.
3. The two groups will be similar with respect to changes from baseline in serum viral RNA and CD4 counts and will continue to be so after 48 weeks.

Patients are randomized to one of two regimens: a control regimen of indinavir plus DMP 266 or an experimental regimen of indinavir plus DMP 266, each at different doses than in the control regimen.

• Study Type: Interventional
• Enrollment: 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 921036329
      • UCSD Treatment Ctr / Dept of Medicine & Pediatrics
    • San Francisco, California, United States, 94110
      • San Francisco Gen Hosp
  • Colorado
    • Denver, Colorado, United States, 80262
      • Univ of Colorado / Health Science Ctr
  • Hawaii
    • Honolulu, Hawaii, United States, 96816
      • Hawaii AIDS Clinical Trial Unit
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush Med Ctr / Section of Infectious Diseases
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Hosp
  • New York
    • Stony Brook, New York, United States, 117948153
      • Univ Hosp / SUNY at Stony Brook / AIDS TMT Unit
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Brown Univ / Miriam Hosp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

Patients must have:

• HIV-1 seropositive status.
• CD4 count >= 100 cells/mm3.
• Serum viral RNA levels >= 10,000 copies/ml.

Exclusion Criteria

Prior Medication:

Excluded:

• Prior protease inhibitor therapy.
• Prior non-nucleoside reverse transcriptase inhibitor therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Parallel Assignment

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: June 1, 1999

More Information

Terms related to this study

• Keywords: Reverse Transcriptase Inhibitors; Anti-HIV Agents; Acquired Immunodeficiency Syndrome; HIV Protease Inhibitors; Drug Administration Schedule; Indinavir; efavirenz
• 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; Protease Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; HIV Protease Inhibitors; Viral Protease Inhibitors; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Indinavir; Efavirenz
• Other Study ID Numbers: 246K; 067-00