The purpose of this study is to see whether taking indinavir (IDV) plus ritonavir (RTV) plus stavudine (d4T) plus lamivudine (3TC) 2 times each day is safe and can lower the level of HIV in the blood.

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

Further Study Details: 

Expected Total Enrollment:  80

Patients take IDV plus RTV plus d4T plus 3TC twice daily for 24 weeks. Every 4 weeks, patients have physical exams and laboratory tests of blood and urine, and CD4 cell counts and plasma viral RNA are measured. At Week 24, the proportion of patients with plasma viral RNA below 400 copies/ml is determined to identify any clinically meaningful antiretroviral activity for the drug regimen. An observed response proportion of 80% or higher will be considered clinically meaningful.

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

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV-positive.
• Have a CD4 cell count of 75 cells/mm3 or more and a viral load of 5,000 copies/ml or more.
• Are age 16 or older (consent of a parent or guardian required if under 18).
• Agree to practice abstinence or use barrier methods of birth control (such as condoms).
• Are willing to stop taking all anti-HIV drugs except study drugs. (Patients may be able to continue taking drugs for other infections.)

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have cancer, lung disease, severe hepatitis, or active AIDS-related infections. (Certain AIDS-related infections such as Kaposi's sarcoma may be allowed).
• Have ever taken 3TC, abacavir (ABC), or a protease inhibitor (such as IDV or RTV).
• Have changed their medications in the last 2 weeks.
• Are allergic to IDV, RTV, d4T, or 3TC.
• Have used certain medications (see the technical summary for more detail).
• Are pregnant or breast-feeding.

Alabama
      Univ of Alabama at Birmingham, Birmingham,  Alabama,  35294,  United States
California
      Univ of California at San Francisco Gen Hosp, San Francisco,  California,  94110,  United States
      Kaiser Foundation Hospital, San Francisco,  California,  94118,  United States
      HIV Institute / Davies Med Ctr, San Francisco,  California,  94114,  United States
      Apogee Med Group, San Diego,  California,  92101,  United States
Florida
      Univ of Miami School of Medicine, Miami,  Florida,  33136,  United States
Illinois
      AIDS Research Alliance - Chicago, Chicago,  Illinois,  60657,  United States
Louisiana
      Tulane Univ School of Medicine, New Orleans,  Louisiana,  70112,  United States
Massachusetts
      CRI New England, Brookline,  Massachusetts,  02146,  United States
New York
      Mount Sinai Med Ctr, New York,  New York,  10029,  United States
      Montefiore Med Ctr, Bronx,  New York,  10467,  United States
      Bronx Lebanon Hosp Ctr, Bronx,  New York,  10456,  United States
      Chelsea Village Med Ctr, New York,  New York,  10014,  United States
      Liberty Med Group, New York,  New York,  10016,  United States
      St Lukes / Roosevelt Hosp / HIV Center, New York,  New York,  10019,  United States
      SUNY Health Sciences Ctr, Brooklyn,  New York,  11203,  United States
Pennsylvania
      Mark Watkins, Philadelphia,  Pennsylvania,  19107,  United States
Texas
      Univ of Texas / Thomas Street Clinic, Houston,  Texas,  77030,  United States

Study ID Numbers:  246T; 094-00; CRX463
Record last reviewed:  July 2001
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002241
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08