To evaluate the efficacy of Saquinavir-SGC combination with Zidovudine and Lamivudine in the treatment of HIV-1 infected patients with no previous anti-retroviral drug therapy.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Saquinavir  Drug: Lamivudine  Drug: Zidovudine	Phase III

Further Study Details: 

Expected Total Enrollment:  40

All enrolled patients will receive the following 3 drug combination: Saquinavir, Zidovudine and Lamivudine. Efficacy and duration of anti-viral response will be evaluated by monitoring of HIV-1 RNA levels. Patients below the detectable limit of 200 copies/ml will be analyzed using the Ultra-direct method with a detection limit of 20 copies/ml. CD4 and CD8 cell counts will also be analyzed.

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

Criteria

Inclusion Criteria

Patients must have:

• Plasma HIV-1 RNA titers > 10,000 copies/ml.
• CD4 cell count > 100 cells/mm3.

Exclusion Criteria

Co-existing Condition: Patients with any of the following conditions will be excluded:

• Any prior anti-retroviral drug therapy. Prior Medication: Excluded: Previous anti-retroviral drug therapy.

California
      AIDS Healthcare Foundation Labs, Los Angeles,  California,  90048,  United States
Florida
      Urgent Care Ctr / North Broward Hosp District, Fort Lauderdale,  Florida,  33316,  United States

Study ID Numbers:  229F; NR15503; M61005
Record last reviewed:  August 1997
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002367
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08