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).

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Indinavir sulfate	Phase III

Further Study Details: 

Expected Total Enrollment:  350

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.

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Patients must have:

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

Alabama
      1917 Research Clinic, Birmingham,  Alabama,  35294,  United States
California
      Ctr for AIDS Research / Education and Service (CARES), Sacramento,  California,  95814,  United States
      San Francisco Gen Hosp / UCSF AIDS Program, San Francisco,  California,  94110,  United States
      Tower ID Med Associates, Los Angeles,  California,  90048,  United States
      Kaiser Permanente / Infectious Disease, Los Angeles,  California,  90027,  United States
Florida
      Univ of Miami School of Medicine, Miami,  Florida,  33136,  United States
      HIV Clinical Research, Fort Lauderdale,  Florida,  33316,  United States
Georgia
      Ponce de Leon Ctr, Atlanta,  Georgia,  30308,  United States
      AIDS Research Consortium of Atlanta, Atlanta,  Georgia,  30308,  United States
Illinois
      Rush Presbyterian St Lukes Med Ctr, Chicago,  Illinois,  60612,  United States
      Northwestern Univ Med School, Chicago,  Illinois,  60611,  United States
Maryland
      Natl Naval Med Ctr / Special Immunology Clinic, Bethesda,  Maryland,  20889,  United States
Massachusetts
      Boston Med Ctr / Clinical Research Office, Boston,  Massachusetts,  02118,  United States
      Brigham and Women's Hosp, Boston,  Massachusetts,  02115,  United States
Michigan
      Univ Health Ctr 7D, Detroit,  Michigan,  48201,  United States
Missouri
      Kansas City Free Health Clinic, Kansas City,  Missouri,  64111,  United States
New Jersey
      Education & Research Building, Camden,  New Jersey,  08103,  United States
      Garden State Infectious Diseases / E I P Kennedy Health Sys, Voorhees,  New Jersey,  08043,  United States
New York
      SUNY / Health Science Ctr at Brooklyn, Brooklyn,  New York,  11203,  United States
      Albany Med College / Div of HIV Medicine, Albany,  New York,  12208,  United States
      CRIA, New York,  New York,  10001,  United States
      Anderson Clinical Research, New York,  New York,  10016,  United States
      New York Hosp of Queens / AIDS Ctr, Flushing,  New York,  11355,  United States
      St Vincents Hosp and Med Ctr / Div of HIV Med, New York,  New York,  10011,  United States
Ohio
      Akron City Hospital, Akron,  Ohio,  44304,  United States
Pennsylvania
      Anderson Clinical Research, Pittsburgh,  Pennsylvania,  15213,  United States
      Thomas Jefferson Univ, Philadelphia,  Pennsylvania,  19107,  United States
Texas
      Houston Clinical Research Network / Southhampton Med Group, Houston,  Texas,  77098,  United States
Utah
      Univ of Utah School Of Medicine / Div of Infec Disease, Salt Lake City,  Utah,  84132,  United States

Study ID Numbers:  246P; MK-0639
Record last reviewed:  June 1999
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002406
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08