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

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

MedlinePlus related topics:

AIDS Nausea and Vomiting

ChemIDplus related topics:

Indinavir Indinavir Sulfate Efavirenz

U.S. FDA Resources

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 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

Study ID Numbers:	246K, 067-00
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002387
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

Study placed in the following topic categories:

Virus Diseases

Efavirenz

Sexually Transmitted Diseases, Viral

Indinavir

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents

RNA Virus Infections

HIV Protease Inhibitors

Slow Virus Diseases

Anti-HIV Agents

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Reverse Transcriptase Inhibitors

Protease Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 16, 2008

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