Clinical trial NCT00002424: A Study to Compare the Safety and Effectiveness of Indinavir Combined With Stavudine and Lamivudine
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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Drug Administration Schedule
Stavudine
HIV Protease Inhibitors
Lamivudine
Indinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

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 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.

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