A Study to Compare the Safety and Effectiveness of Indinavir Combined With Stavudine and Lamivudine - Full Text View

Purpose

This study will see how safe and effective against HIV the drugs L-756423 plus indinavir (IDV) are compared to just IDV when taken with stavudine (d4T) and lamivudine (3TC). The study will also see whether taking 1 large dose of L-756423/IDV once a day is as safe and effective as taking 2 smaller doses twice a day.

Condition	Intervention	Phase
HIV Infections	Drug: L-756423 Drug: Indinavir sulfate Drug: Lamivudine Drug: Stavudine	Phase II

MedlinePlus related topics:

AIDS

Drug Information available for:

Lamivudine Indinavir Indinavir Sulfate Stavudine L 756423

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Safety Study

Official Title:	A Multicenter, Double-Blind, Randomized Pilot Study to Compare the Safety and Activity of L-756423/Indinavir, 1600/800 Mg Qd or 800/400 Mg Bid Versus Indinavir, 800 Mg q8h, All in Combination With Stavudine and Lamivudine

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

Estimated Enrollment:

186

Detailed Description:

Patients are randomized to 1 of 4 treatment arms. In Group 1, patients receive a dose of L-756423/IDV once daily plus IDV placebo. In Group 3, patients receive a lower dose of L-756423/IDV twice daily (with the daily dosage equaling that of Group 1) plus IDV placebo. In Groups 2 and 4, patients receive equal dosages of IDV plus L-756423/IDV placebo. In all 4 groups L-756423 and IDV are blinded to the investigator and patient. All groups receive open-label d4T and 3TC. Patients routinely undergo a physical exam and have blood and urine tests to ensure the drugs' safety and tolerability, which will be evaluated by tabulation of adverse events and clinical assessment of laboratory data. In addition, CD4+ T cell and plasma viral RNA levels are measured to quantify the drugs' antiretroviral activity.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

You may be eligible for this trial if you:

Have HIV infection.
Have levels of CD4 cells of 100 cells/mm3 or greater.
Have a viral load of 10,000 copies/ml or greater.
Are 18 years of age or older.

Exclusion Criteria

You may not be eligible for this trial if you:

Have ever taken anti-HIV drugs.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002424

Locations


United States, California
	UCLA School of Medicine / Ctr for Research and Education
	Los Angeles, California, United States, 900951793

United States, District of Columbia
	Georgetown Univ Med Ctr
	Washington, District of Columbia, United States, 20007
	ViRx / Dupont Circle Physicians Group
	Washington, District of Columbia, United States, 20009

United States, Florida
	Associates in Research
	Fort Myers, Florida, United States, 33901
	Univ of Miami School of Medicine
	Miami, Florida, United States, 33136

United States, Georgia
	Grady Mem Hosp
	Atlanta, Georgia, United States, 30308

United States, Illinois
	Rush Presbyterian - Saint Luke's Med Ctr
	Chicago, Illinois, United States, 60612
	The CORE Ctr
	Chicago, Illinois, United States, 60612

United States, Kentucky
	Univ of Kentucky Med Ctr
	Lexington, Kentucky, United States, 40536
	Univ of Kentucky
	Lexington, Kentucky, United States, 40536

United States, Massachusetts
	Beth Israel Deaconess Med Ctr
	Boston, Massachusetts, United States, 02215

United States, Michigan
	Henry Ford Hosp
	Detroit, Michigan, United States, 48202

United States, New York
	Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
	New York, New York, United States, 10021
	SUNY at Stony Brook / Div of Infectious Disease
	Stony Brook, New York, United States, 117948153
	NYU Med Ctr / C & D Building
	New York, New York, United States, 10016

United States, Rhode Island
	The Miriam Hosp
	Providence, Rhode Island, United States, 02906

Sponsors and Collaborators

Merck

More Information

Study ID Numbers:	300B, 009-01, 009-00
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002424
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Drug Therapy, Combination

Drug Administration Schedule

Stavudine

HIV Protease Inhibitors

Lamivudine

Indinavir

Reverse Transcriptase Inhibitors

Anti-HIV Agents

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

Stavudine

Indinavir

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Lamivudine

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

Sponsored by:	Merck
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002424