This study will see how safe and effective against HIV the drugs L-756423 plus indinavir (IDV) are compared to just IDV when taken with stavudine (d4T) and lamivudine (3TC). The study will also see whether taking 1 large dose of L-756423/IDV once a day is as safe and effective as taking 2 smaller doses twice a day.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: L-756423  Drug: Indinavir sulfate  Drug: Lamivudine  Drug: Stavudine	Phase II

Further Study Details: 

Expected Total Enrollment:  186

Patients are randomized to 1 of 4 treatment arms. In Group 1, patients receive a dose of L-756423/IDV once daily plus IDV placebo. In Group 3, patients receive a lower dose of L-756423/IDV twice daily (with the daily dosage equaling that of Group 1) plus IDV placebo. In Groups 2 and 4, patients receive equal dosages of IDV plus L-756423/IDV placebo. In all 4 groups L-756423 and IDV are blinded to the investigator and patient. All groups receive open-label d4T and 3TC. Patients routinely undergo a physical exam and have blood and urine tests to ensure the drugs' safety and tolerability, which will be evaluated by tabulation of adverse events and clinical assessment of laboratory data. In addition, CD4+ T cell and plasma viral RNA levels are measured to quantify the drugs' antiretroviral activity.

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

Criteria

Inclusion Criteria

You may be eligible for this trial if you:

• Have HIV infection.
• Have levels of CD4 cells of 100 cells/mm3 or greater.
• Have a viral load of 10,000 copies/ml or greater.
• Are 18 years of age or older.

Exclusion Criteria

You may not be eligible for this trial if you:

• Have ever taken anti-HIV drugs.

California
      UCLA School of Medicine / Ctr for Research and Education, Los Angeles,  California,  900951793,  United States
District of Columbia
      Georgetown Univ Med Ctr, Washington,  District of Columbia,  20007,  United States
      ViRx / Dupont Circle Physicians Group, Washington,  District of Columbia,  20009,  United States
Florida
      Associates in Research, Fort Myers,  Florida,  33901,  United States
      Univ of Miami School of Medicine, Miami,  Florida,  33136,  United States
Georgia
      Grady Mem Hosp, Atlanta,  Georgia,  30308,  United States
Illinois
      Rush Presbyterian - Saint Luke's Med Ctr, Chicago,  Illinois,  60612,  United States
      The CORE Ctr, Chicago,  Illinois,  60612,  United States
Kentucky
      Univ of Kentucky Med Ctr, Lexington,  Kentucky,  40536,  United States
      Univ of Kentucky, Lexington,  Kentucky,  40536,  United States
Massachusetts
      Beth Israel Deaconess Med Ctr, Boston,  Massachusetts,  02215,  United States
Michigan
      Henry Ford Hosp, Detroit,  Michigan,  48202,  United States
New York
      Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ, New York,  New York,  10021,  United States
      SUNY at Stony Brook / Div of Infectious Disease, Stony Brook,  New York,  117948153,  United States
      NYU Med Ctr / C & D Building, New York,  New York,  10016,  United States
Rhode Island
      The Miriam Hosp, Providence,  Rhode Island,  02906,  United States

Study ID Numbers:  300B; 009-01; 009-00
Record last reviewed:  April 2000
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002424
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08