Clinical Trial: The Safety and Effectiveness of Indinavir Sulfate Plus Efavirenz

This study has been completed.

Sponsored by: Merck Research Laboratories
Information provided by: AIDS Clinical Trials Information Service

Purpose

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.

Condition Treatment or Intervention
HIV Infections
 Drug: Indinavir sulfate
 Drug: Efavirenz

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety Study

Official Title: 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.

Further Study Details: 

Expected Total Enrollment:  80

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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.

Location Information


California
      San Francisco Gen Hosp, San Francisco,  California,  94110,  United States

      UCSD Treatment Ctr / Dept of Medicine & Pediatrics, San Diego,  California,  921036329,  United States

Colorado
      Univ of Colorado / Health Science Ctr, Denver,  Colorado,  80262,  United States

Hawaii
      Hawaii AIDS Clinical Trial Unit, Honolulu,  Hawaii,  96816,  United States

Illinois
      Rush Med Ctr / Section of Infectious Diseases, Chicago,  Illinois,  60612,  United States

Massachusetts
      Beth Israel Hosp, Boston,  Massachusetts,  02215,  United States

New York
      Univ Hosp / SUNY at Stony Brook / AIDS TMT Unit, Stony Brook,  New York,  117948153,  United States

Rhode Island
      Brown Univ / Miriam Hosp, Providence,  Rhode Island,  02906,  United States

More Information

Study ID Numbers:  246K; 067-00
Record last reviewed:  June 1999
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002387
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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