The Safety and Effectiveness of Indinavir Sulfate Plus Efavirenz - Full Text View

Sponsor:	Merck
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002387

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:

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.
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.
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	Intervention
HIV Infections	Drug: Indinavir sulfate Drug: Efavirenz

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.

Resource links provided by NLM:

MedlinePlus related topics: AIDS Nausea and Vomiting

Drug Information available for: Indinavir Efavirenz Indinavir Sulfate

U.S. FDA Resources

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

Estimated Enrollment:

80

Detailed Description:

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

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.
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.
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 older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002387

Locations

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

Sponsors and Collaborators

Merck

More Information

No publications provided

Study ID Numbers:	246K, 067-00
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002387 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Acquired Immunodeficiency Syndrome
Drug Administration Schedule
HIV Protease Inhibitors
Indinavir

Reverse Transcriptase Inhibitors
Anti-HIV Agents
efavirenz

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Indinavir
Molecular Mechanisms of Pharmacological Action
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
Efavirenz
RNA Virus Infections

HIV Protease Inhibitors
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 November 27, 2009