A Study to Compare the Safety and Effectiveness of Indinavir Combined With Stavudine and Lamivudine

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00002424
• Other study ID #: 300B
• Secondary ID: 009-01009-00
• Status: Suspended
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: April 2000
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 186
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• L-756423

• Indinavir sulfate

• Lamivudine

• Stavudine

Locations

Country	Name	City	State
United States	Grady Mem Hosp	Atlanta	Georgia
United States	Beth Israel Deaconess Med Ctr	Boston	Massachusetts
United States	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois
United States	The CORE Ctr	Chicago	Illinois
United States	Henry Ford Hosp	Detroit	Michigan
United States	Associates in Research	Fort Myers	Florida
United States	Univ of Kentucky	Lexington	Kentucky
United States	Univ of Kentucky Med Ctr	Lexington	Kentucky
United States	UCLA School of Medicine / Ctr for Research and Education	Los Angeles	California
United States	Univ of Miami School of Medicine	Miami	Florida
United States	Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ	New York	New York
United States	NYU Med Ctr / C & D Building	New York	New York
United States	The Miriam Hosp	Providence	Rhode Island
United States	SUNY at Stony Brook / Div of Infectious Disease	Stony Brook	New York
United States	Georgetown Univ Med Ctr	Washington	District of Columbia
United States	ViRx / Dupont Circle Physicians Group	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States,