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 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS HIV/AIDS Medicines

Drug Information available for: Stavudine Lamivudine Indinavir Indinavir sulfate

U.S. FDA Resources

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
The CORE Ctr
Chicago, Illinois, United States, 60612
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
United States, Kentucky
Univ of Kentucky
Lexington, Kentucky, United States, 40536
Univ of Kentucky Med Ctr
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
NYU Med Ctr / C & D Building
New York, New York, United States, 10016
SUNY at Stony Brook / Div of Infectious Disease
Stony Brook, New York, United States, 117948153
United States, Rhode Island
The Miriam Hosp
Providence, Rhode Island, United States, 02906

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

More Information

No publications provided


ClinicalTrials.gov Identifier:	NCT00002424 History of Changes
Other Study ID Numbers:	300B, 009-01, 009-00
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
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

Additional relevant MeSH terms:


Indinavir Lamivudine Stavudine Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antimetabolites Antiviral Agents	Enzyme Inhibitors HIV Protease Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Protease Inhibitors Reverse Transcriptase Inhibitors Therapeutic Uses

ClinicalTrials.gov processed this record on March 02, 2015