The purpose of this study is to see if it is safe and effective to give indinavir plus ritonavir plus 2 NRTIs to HIV-infected patients who need early intervention treatment.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Indinavir sulfate  Drug: Ritonavir	Phase II

Further Study Details: 

Expected Total Enrollment:  100

Patients receive indinavir bid plus ritonavir bid, plus 2 NRTIs bid (2 new NRTIs or 1 new NRTI and 1 NRTI without evidence of resistance). CD4 cell counts and plasma viral RNA are measured every 4 weeks for the duration of the study. Physical examination and laboratory tests of blood and urine are performed every 4 weeks for the duration of the study. Chest x-ray and 12-lead ECG are done prestudy.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV-positive.
• Are 18 years of age or older.
• Have a CD4 cell count of at least 50 cells/mm3.
• Have a viral load (level of HIV in the blood) of at least 400 copies/ml but no more than 20,000 copies/ml.
• Have had an initial response to protease inhibitor therapy with a viral load of less than 400 copies/ml in two consecutive tests at least 1 week apart.
• Have been on anti-HIV (antiretroviral) treatment including indinavir or nelfinavir for at least 16 weeks.
• Have had virologic failure (two consecutive viral loads that were greater than or equal to 400 copies/ml and less than or equal to 20,000 copies/ml at least 1 week apart) that is not due to another infection, vaccination, or a temporary stop in treatment.
• Are naive to at least one of the selected NRTIs.

California
      Harbor - UCLA Med Ctr, Torrance,  California,  90502,  United States
      UCSD Med Ctr - Owen Clinic, San Diego,  California,  921038681,  United States
      San Francisco Veterans Adm Med Cntr, San Francisco,  California,  94121,  United States
      Tower Infectious Diseases / Med Associates Inc, Los Angeles,  California,  90048,  United States
      Pacific Oaks Research, Beverly Hills,  California,  90211,  United States
      HIV Institute / Davies Med Ctr, San Francisco,  California,  94114,  United States
      Ocean View Internal Medicine, Long Beach,  California,  90803,  United States
      Avalar Medical Group, Tarzana,  California,  91356,  United States
      Bisher Akil, Los Angeles,  California,  90046,  United States
Colorado
      Benjamin Young, Denver,  Colorado,  80220,  United States
Connecticut
      University of Connecticut Health Center, Farmington,  Connecticut,  06030,  United States
Florida
      IDC Research Initiative, Altamonte Springs,  Florida,  32701,  United States
      Hillsborough County Health Dept, Tampa,  Florida,  33602,  United States
Georgia
      Mercer University School of Medicine, Macon,  Georgia,  31201,  United States
Idaho
      Thomas Coffman MD, Boise,  Idaho,  83712,  United States
Illinois
      Chicago Ctr for Clinical Research, Chicago,  Illinois,  60610,  United States
      Northwestern Univ / Infect Dis Div / Pasavant Pav 828, Chicago,  Illinois,  60611,  United States
      The CORE Ctr, Chicago,  Illinois,  60612,  United States
Kansas
      Univ of Kansas School of Medicine, Wichita,  Kansas,  67214,  United States
Kentucky
      University of Louisville / ID Division, Louisville,  Kentucky,  40202,  United States
Louisiana
      Tulane Univ School of Medicine, New Orleans,  Louisiana,  70112,  United States
Maryland
      Institute of Human Virology, Baltimore,  Maryland,  21201,  United States
Massachusetts
      New England Med Ctr, Boston,  Massachusetts,  02111,  United States
New Jersey
      Dr Ronald Nahass, Somerville,  New Jersey,  08876,  United States
      Cooper Hospital Early Intervention Program, Camden,  New Jersey,  08103,  United States
New York
      Bronx Veterans Affairs Med Ctr, Bronx,  New York,  10468,  United States
      Bellevue Hosp Ctr, New York,  New York,  10016,  United States
      St Vincents Hosp / Clinical Research Program, New York,  New York,  10011,  United States
      SUNY at Stony Brook / Div of Infectious Disease, Stony Brook,  New York,  117948153,  United States
      St Luke Roosevelt Hosp, New York,  New York,  10011,  United States
      Mount Sinai Med Ctr, New York,  New York,  100296574,  United States
      Mt Vernon Hosp, Mt. Vernon,  New York,  10550,  United States
      Gramercy Park Physicians LLP, New York,  New York,  10003,  United States
North Carolina
      Wake Forest Univ School of Medicine, Winston Salem,  North Carolina,  27157,  United States
Oklahoma
      Oklahoma Univ Health Science Ctr, Oklahoma City,  Oklahoma,  73104,  United States
Oregon
      Fanno Creek Clinic, Portland,  Oregon,  97219,  United States
Pennsylvania
      Anderson Clinical Research, Pittsburgh,  Pennsylvania,  15213,  United States
Texas
      Univ of Texas Med Branch / Div of Infectious Dis, Galveston,  Texas,  775550835,  United States
      Univ of Texas Health Sciences Ctr, San Antonio,  Texas,  782847838,  United States
      Thomas Street Clinic, Houston,  Texas,  77009,  United States

Study ID Numbers:  246V; CRX481; 107-00
Record last reviewed:  July 2001
Last Updated:  October 13, 2004
Record first received:  April 7, 2000
ClinicalTrials.gov Identifier:  NCT00005118
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08