To evaluate the antiviral activity and safety of two formulations of saquinavir in combination with licensed nucleoside antiretroviral drugs.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Saquinavir  Drug: Lamivudine  Drug: Stavudine  Drug: Zidovudine  Drug: Zalcitabine  Drug: Didanosine	Phase II

Further Study Details: 

Expected Total Enrollment:  140

Patients are randomized to receive either hard gel or soft gel capsules of saquinavir in combination with at least one licensed nucleoside antiretroviral. Treatment will continue for 48 weeks. After the first 16 weeks, patients will be given the opportunity to roll over to the saquinavir formulation of choice.

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Patients must have:

• HIV infection.
• Antiretroviral naiveness (i.e., less than 4 weeks of prior treatment) to at least one of the licensed nucleoside drugs.
• No more than 2 weeks of prior treatment with a protease inhibitor.
• No active opportunistic infection or other serious AIDS-defining condition.

Exclusion Criteria

Co-existing Condition: Patients with the following symptoms or conditions are excluded:

• Malabsorption or inadequate oral intake.
• Lab or clinical abnormality worse than grade 3 (other than exercise-induced CPK elevations).
• Unexplained, chronic diarrhea, defined as more than three loose stools per day persisting for 2 weeks or more within the month prior to study entry.
• Active malignancy or anticipated need for chemotherapy during the study.
• Anticipated need for disallowed medications during the study. Concurrent Medication: Excluded:
• Other protease inhibitors. Prior Medication: Excluded:
• More than 4 weeks of the prior nucleoside antiretroviral selected for the patient's regimen.
• More than 2 weeks of any protease inhibitor.

Arizona
      Phoenix Body Positive, Phoenix,  Arizona,  85016,  United States
California
      UCD Med Ctr, Sacramento,  California,  95817,  United States
      San Francisco Veterans Adm Med Cntr, San Francisco,  California,  94121,  United States
      UCSD Treatment Ctr, San Diego,  California,  921036329,  United States
      Mount Zion Hosp of UCSF, San Francisco,  California,  94115,  United States
      AIDS Research Ctr, Palo Alto,  California,  94304,  United States
      UCLA AIDS Clinical Research Ctr / Dept of Medicine, Los Angeles,  California,  90024,  United States
Colorado
      Univ of Colorado Health Sciences Ctr, Denver,  Colorado,  80262,  United States
District of Columbia
      Whitman Walker Clinic, Washington,  District of Columbia,  20009,  United States
Florida
      Miami Veterans Administration Med Ctr, Miami,  Florida,  33125,  United States
      Saint Joseph's Hosp, Tampa,  Florida,  33614,  United States
Georgia
      AIDS Research Consortium of Atlanta, Atlanta,  Georgia,  30308,  United States
Illinois
      Rush Presbyterian - Saint Luke's Med Ctr, Chicago,  Illinois,  60612,  United States
      Cook County Hosp, Chicago,  Illinois,  60612,  United States
Louisiana
      Tulane Univ / Tulane / LSU Clinical Trials Unit, New Orleans,  Louisiana,  70122,  United States
Massachusetts
      Harvard Univ / Massachusetts Gen Hosp, Boston,  Massachusetts,  02114,  United States
      New England Med Ctr, Boston,  Massachusetts,  02111,  United States
New York
      Beth Israel Med Ctr, New York,  New York,  10003,  United States
      St Vincents Hosp and Med Ctr / AIDS Cntr Progrm, New York,  New York,  10011,  United States
Oklahoma
      Univ of Oklahoma, Oklahoma City,  Oklahoma,  73117,  United States
Pennsylvania
      Univ of Pennsylvania / Division of Infectious Disease, Philadelphia,  Pennsylvania,  19104,  United States
Texas
      Infectious Diseases Association of Houston, Houston,  Texas,  77030,  United States
      Univ of Texas Med Branch, Galveston,  Texas,  775550835,  United States
Canada, Alberta
      Southern Alberta HIV Clinic / Foot Hills Hosp, Calgary,  Alberta,  Canada
Canada, British Columbia
      Saint Paul's Hosp / Canadian HIV Trials Network, Vancouver,  British Columbia,  Canada
Canada, Ontario
      McMaster Univ Med Ctr, Hamilton,  Ontario,  Canada
Canada, Quebec
      Montreal Gen Hosp / Div of Clin Immuno and Allergy, Montreal,  Quebec,  Canada

Study ID Numbers:  229D; NV15355
Record last reviewed:  August 1997
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002162
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08