Clinical trial NCT00002430: A Study to Compare the Effectiveness of Two Anti-HIV Drug Combinations
Official title: A Multicenter, Open-Label, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate/d4T/3TC Versus Indinavir Sulfate/Nelfinavir Mesylate/d4T/3TC in HIV-Infected Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
HIV Protease Inhibitors
Lamivudine
Indinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Nelfinavir
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 220
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two different anti-HIV drug combinations, one that contains nelfinavir (NFV) and one that does not. The best dosing schedule for indinavir (IDV) also will be studied.

Detailed description: Patients are stratified by screening plasma viral RNA results (50,000 copies/ml or below vs above 50,000 copies/ml) and randomized to 1 of 2 treatment arms. Group 1 receives IDV 3 times daily plus d4T/3TC twice daily. Group 2 receives IDV/NFV/d4T/3TC twice daily. Patients remain on study medications for 24 weeks and are seen at the clinic once every 4 weeks after entering the study. At each clinic visit, blood samples are taken to evaluate CD4 cell count and plasma HIV RNA levels.

Eligibility criteria: Inclusion Criteria

You may be eligible for this study if you:

* Are HIV positive.
* Have a viral load (level of HIV in your blood) of at least 10,000 copies/ml within 45 days of study entry.
* Have a CD4 cell count of at least 100 cells/mm3 within 45 days of study entry.
* Have a normal chest X-ray.
* Have never taken protease inhibitors or 3TC.
* Are 16 years of age or older.
* Agree to practice sexual abstinence or use barrier methods of birth control (e.g., condoms).

Exclusion Criteria

You will not be eligible for this study if you:

* Have an active opportunistic (AIDS-related) infection or cancer.
* Have certain types of Kaposi's sarcoma.
* Have hepatitis.
* Have chronic diarrhea.
* Have a history of certain medical conditions.
* Are allergic to any of the study medications.
* Are taking certain medications.
* Are pregnant or breast-feeding.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Univ of Alabama School of Med
state: Alabama
city: Long Beach
country: United States
facility: Ocean View Internal Medicine
state: California
city: Los Angeles
country: United States
facility: AIDS Healthcare Foundation
state: California
city: Los Angeles
country: United States
facility: Tower ID Med Associates
state: California
city: Los Angeles
country: United States
facility: Oasis Clinic / King Drew Med Ctr
state: California
city: Oakland
country: United States
facility: Robert Scott MD
state: California
city: Redwood City
country: United States
facility: AIDS Community Research Consortium
state: California
city: San Francisco
country: United States
facility: Saint Francis Mem Hosp / HIV Care Unit
state: California
city: San Francisco
country: United States
facility: Pacific Horizons Med Group
state: California
city: San Francisco
country: United States
facility: Kaiser Foundation Hospital
state: California
city: Torrance
country: United States
facility: Harbor - UCLA Med Ctr
state: California
city: Denver
country: United States
facility: Denver Public Health Dept
state: Colorado
city: Stamford
country: United States
facility: Blick Med Associates
state: Connecticut
city: Washington
country: United States
facility: Physicans Home Service
state: District of Columbia
city: Altamonte Springs
country: United States
facility: IDC Research Initiative
state: Florida
city: Miami
country: United States
facility: Univ of Miami School of Medicine
state: Florida
city: Tampa
country: United States
facility: Hillsborough County Health Dept
state: Florida
city: Atlanta
country: United States
facility: Emory Univ
state: Georgia
city: Macon
country: United States
facility: Harold Katner MD
state: Georgia
city: Boise
country: United States
facility: Thomas Coffman MD
state: Idaho
city: Chicago
country: United States
facility: Chicago Ctr for Clinical Research
state: Illinois
city: Chicago
country: United States
facility: Northwestern Univ Med Ctr
state: Illinois
city: Chicago
country: United States
facility: Univ of Illinois
state: Illinois
city: Lexington
country: United States
facility: Kentucky Clinical Research
state: Kentucky
city: New Orleans
country: United States
facility: Louisiana State Univ Med Ctr / Tulane Med School
state: Louisiana
city: Portland
country: United States
facility: AIDS Consultation Service / Maine Med Ctr
state: Maine
city: Baltimore
country: United States
facility: Institute of Human Virology
state: Maryland
city: Boston
country: United States
facility: JSI Research and Training Institute
state: Massachusetts
city: Camden
country: United States
facility: Education & Research Building
state: New Jersey
city: Newark
country: United States
facility: NJCRI
state: New Jersey
city: Union
country: United States
facility: Infectious Disease Specialists of NJ
state: New Jersey
city: Brooklyn
country: United States
facility: Brookdale Univ Hosp and Med Ctr
state: New York
city: New York
country: United States
facility: Liberty Med Group
state: New York
city: New York
country: United States
facility: James Jones MD
state: New York
city: New York
country: United States
facility: Mount Sinai Med Ctr
state: New York
city: Rochester
country: United States
facility: Community Health Network
state: New York
city: Winston Salem
country: United States
facility: Wake Forest Univ School of Medicine
state: North Carolina
city: Tulsa
country: United States
facility: Associates in Med and Mental Health
state: Oklahoma
city: Portland
country: United States
facility: The Research and Education Group
state: Oregon
city: Portland
country: United States
facility: Fanno Creek Clinic
state: Oregon
city: Pittsburgh
country: United States
facility: Anderson Clinical Research / Inc
state: Pennsylvania
city: Columbia
country: United States
facility: Burnside Clinic
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt Univ Med Ctr
state: Tennessee
city: Dallas
country: United States
facility: Oak Lawn Physicians Group
state: Texas
city: Galveston
country: United States
facility: Univ TX Galveston Med Branch
state: Texas
city: Tacoma
country: United States
facility: Infections Ltd / Physicians Med Ctr
state: Washington
Study officials:
References: