To examine the efficacy of saquinavir SGC (soft gel capsules) in combination with other antiretrovirals in HIV-1 infected patients currently treated with saquinavir HGC (hard gel capsules) measured by the absolute change in plasma HIV-1 RNA during the 24 weeks of study treatment.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Ritonavir  Drug: Nelfinavir mesylate  Drug: Saquinavir  Drug: Stavudine	Phase III

Further Study Details: 

Expected Total Enrollment:  120

Eligible patients will be stratified by HIV-1 RNA level into 2 populations: 1) >= 5,000-30,000 HIV-1 RNA, 2) > 30,000 HIV-1 RNA. All patients will be randomized to 1 of 3 treatment arms: Arm A - Saquinavir soft gel capsules (SQV SGC) + 2 new nucleoside analogs (reverse transcriptase inhibitors [RTIs]), Arm B - SQV SGC + nelfinavir + stavudine (d4T) or a new RTI, or Arm C - SQV SGC + ritonavir + d4T or a new RTI. All patients will undergo plasma HIV-1 RNA determinations, CD4 lymphocyte counts, hematology and chemistry blood work at baseline, weeks 4, 8, 12, 16 and 24.

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

Criteria

Inclusion Criteria

Patients must have:

• Documented HIV infection.
• CD4 > 100 cells/mm3.
• Saquinavir HGC-experienced patients (>= 3 months cumulative therapy).

Required: >= 3 months cumulative saquinavir HGC therapy.

California
      Tower Infectious Diseases / Med Associates Inc, Los Angeles,  California,  90048,  United States
      Pacific Oaks Med Ctr, Beverly Hills,  California,  90211,  United States
Florida
      Community Research Initiative of South Florida, Coral Gables,  Florida,  33146,  United States
      Ctr for Quality Care, Tampa,  Florida,  33609,  United States
Massachusetts
      Community Research Initiative of New England, Brookline,  Massachusetts,  02445,  United States
New York
      AIDS Ctr, New York,  New York,  10011,  United States
Pennsylvania
      Anderson Clinical Research / Inc, Pittsburgh,  Pennsylvania,  15213,  United States

Study ID Numbers:  229G; NR15521
Record last reviewed:  August 1997
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002374
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08