Clinical trial NCT00002406: A Comparison of Two Dose Levels of Indinavir Combined With Two Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) in HIV-Infected Patients
Official title: A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulphate, 800 Mg q 8h Versus 1,200 Mg q 12h in HIV-Infected Individuals Having Plasma Viral RNA Less Than 400 Copies/Ml, on Concomitant Therapy With 2 Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV-1
Dose-Response Relationship, Drug
HIV Protease Inhibitors
Indinavir
RNA, Viral
Reverse Transcriptase Inhibitors
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 350
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 determine if two dose levels of indinavir combined with two nucleoside analogue reverse transcriptase inhibitors (NRTIs) have the same effect on plasma viral load (level of HIV in the blood).

Detailed description: In this open-label study 350 seropositive HIV-1 men and women are first stratified according to baseline plasma viral RNA (less than 400 copies/mL vs negative plasma viral RNA result) then randomized into one of two arms:

Arm 1: Indinavir (800 mg, q8h) plus two pre-existing NRTIs. Arm 2: Indinavir (1,200 mg, q12h) plus two pre-existing NRTIs. Plasma viral RNA will be measured every 4 weeks for the duration of the 24-week study.

Eligibility criteria: Inclusion Criteria

Patients must have:

* Documented HIV-1 seropositive status.
* CD4 count greater than 100 cells/mm3.
* Parental consent for patients under 18.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 1917 Research Clinic
state: Alabama
city: Los Angeles
country: United States
facility: Kaiser Permanente / Infectious Disease
state: California
city: Los Angeles
country: United States
facility: Tower ID Med Associates
state: California
city: Sacramento
country: United States
facility: Ctr for AIDS Research / Education and Service (CARES)
state: California
city: San Francisco
country: United States
facility: San Francisco Gen Hosp / UCSF AIDS Program
state: California
city: Fort Lauderdale
country: United States
facility: HIV Clinical Research
state: Florida
city: Miami
country: United States
facility: Univ of Miami School of Medicine
state: Florida
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Ponce de Leon Ctr
state: Georgia
city: Chicago
country: United States
facility: Northwestern Univ Med School
state: Illinois
city: Chicago
country: United States
facility: Rush Presbyterian St Lukes Med Ctr
state: Illinois
city: Bethesda
country: United States
facility: Natl Naval Med Ctr / Special Immunology Clinic
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hosp
state: Massachusetts
city: Boston
country: United States
facility: Boston Med Ctr / Clinical Research Office
state: Massachusetts
city: Detroit
country: United States
facility: Univ Health Ctr 7D
state: Michigan
city: Kansas City
country: United States
facility: Kansas City Free Health Clinic
state: Missouri
city: Camden
country: United States
facility: Education & Research Building
state: New Jersey
city: Voorhees
country: United States
facility: Garden State Infectious Diseases / E I P Kennedy Health Sys
state: New Jersey
city: Albany
country: United States
facility: Albany Med College / Div of HIV Medicine
state: New York
city: Brooklyn
country: United States
facility: SUNY / Health Science Ctr at Brooklyn
state: New York
city: Flushing
country: United States
facility: New York Hosp of Queens / AIDS Ctr
state: New York
city: New York
country: United States
facility: CRIA
state: New York
city: New York
country: United States
facility: St Vincents Hosp and Med Ctr / Div of HIV Med
state: New York
city: New York
country: United States
facility: Anderson Clinical Research
state: New York
city: Akron
country: United States
facility: Akron City Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson Univ
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Anderson Clinical Research
state: Pennsylvania
city: Houston
country: United States
facility: Houston Clinical Research Network / Southhampton Med Group
state: Texas
city: Salt Lake City
country: United States
facility: Univ of Utah School Of Medicine / Div of Infec Disease
state: Utah
Study officials:
References: