A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 Mg q 8 h Versus 1,200 Mg q 12 h in Combination With Zidovudine and 3TC - Full Text View

A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 Mg q 8 h Versus 1,200 Mg q 12 h in Combination With Zidovudine and 3TC

This study has been completed.

Sponsored by:	Merck
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002208

Purpose

To demonstrate that the antiviral activity and safety/tolerability of a test regimen of indinavir is equivalent to that of a control regimen of indinavir when each is coadministered with zidovudine (ZDV) (or stavudine, d4T) and lamivudine (3TC) for 24 weeks to protease inhibitor- and 3TC-naive HIV-1-seropositive patients. To characterize the steady-state pharmacokinetic profiles of indinavir, ZDV (or d4T), and 3TC in the presence of each other, for both the control and test regimen groups.

Condition	Intervention	Phase
HIV Infections	Drug: Indinavir sulfate Drug: Lamivudine Drug: Stavudine Drug: Zidovudine	Phase III

MedlinePlus related topics:

AIDS

Drug Information available for:

Zidovudine Lamivudine Indinavir Indinavir Sulfate Stavudine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Pharmacokinetics Study

Official Title:	A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 Mg q 8 h Versus 1,200 Mg q 12 h in Combination With Zidovudine and 3TC

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

Estimated Enrollment:

400

Detailed Description:

Patients are randomized to 1 of 2 arms:

Arm A: Indinavir plus ZDV plus 3TC. Arm B: Indinavir (test dose) plus ZDV plus 3TC. NOTE: d4T may be substituted for zidovudine for toxicity management. Patients are stratified based on prior use of nucleoside analogs (naive vs experienced to ZDV, dideoxyinosine [ddI], dideoxycytidine [ddC], and d4T) and screening viral RNA results (lower than 50,000 copies/mL vs more than 50,000 copies/mL).

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patients must have:

HIV-1 seropositive status.
CD4 count greater than 100 cells/mm3.
Viral RNA above 10,000 copies/mL.
Consent from parent or guardian if less than 18 years of age.

Exclusion Criteria

Prior Medication:

Excluded:

Prior therapy with protease inhibitors.
Prior therapy with 3TC.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002208

Locations


United States, Alabama
	Univ of Alabama at Birmingham
	Birmingham, Alabama, United States, 352942050

United States, California
	LAC/USC Med Ctr
	Los Angeles, California, United States, 90033
	Kaiser Med Ctr
	San Francisco, California, United States, 94110

United States, Delaware
	Wilmington Hosp / Med Ctr of Delaware
	Wilmington, Delaware, United States, 19899

United States, District of Columbia
	Georgetown Univ Med Ctr
	Washington, District of Columbia, United States, 20007

United States, Georgia
	AIDS Research Consortium of Atlanta
	Atlanta, Georgia, United States, 30308

United States, Illinois
	Cook County Hosp
	Chicago, Illinois, United States, 60612

United States, Maryland
	Johns Hopkins Hosp
	Baltimore, Maryland, United States, 21287

United States, Missouri
	Washington Univ
	St. Louis, Missouri, United States, 63108

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

United States, Pennsylvania
	Allegheny Univ Hosp
	Philadelphia, Pennsylvania, United States, 19129
	Pittsburgh Treatment Ctr / Univ of Pittsburgh
	Pittsburgh, Pennsylvania, United States, 15261

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

United States, Tennessee
	Vanderbilt Univ Med Ctr
	Nashville, Tennessee, United States, 372321302

United States, Washington
	Univ of Washington / AIDS Clinical Trial Unit
	Seattle, Washington, United States, 98104

Sponsors and Collaborators

Merck

More Information

Publications:

Haas DW, Arathoon E, Thompson MA, de Jesus Pedro R, Gallant JE, Uip DE, Currier J, Noriega LM, Lewi DS, Uribe P, Benetucci L, Cahn P, Paar D, White AC Jr, Collier AC, Ramirez-Ronda CH, Harvey C, Chung MO, Mehrotra D, Chodakewitz J, Nguyen BY. Comparative studies of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine. AIDS. 2000 Sep 8;14(13):1973-8.

Study ID Numbers:	246M, 069-00
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002208
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

HIV-1

Drug Therapy, Combination

Zidovudine

HIV Protease Inhibitors

Lamivudine

Indinavir

Reverse Transcriptase Inhibitors

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

Stavudine

Indinavir

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Lamivudine

Zidovudine

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

HIV Protease Inhibitors

RNA Virus Infections

Anti-HIV Agents

Slow Virus Diseases

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Protease Inhibitors

Reverse Transcriptase Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 03, 2008