A Randomized, Parallel Arm, Comparative, Open Label, Multicenter Study of the Activity and Safety of Two Formulations of Saquinavir in Combination With Other Antiretroviral Drugs
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Saquinavir
Eligibility 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.
Sites / Locations
- Phoenix Body Positive
- UCLA AIDS Clinical Research Ctr / Dept of Medicine
- AIDS Research Ctr
- UCD Med Ctr
- UCSD Treatment Ctr
- Mount Zion Hosp of UCSF
- San Francisco Veterans Adm Med Cntr
- Univ of Colorado Health Sciences Ctr
- Whitman Walker Clinic
- Miami Veterans Administration Med Ctr
- Saint Joseph's Hosp
- AIDS Research Consortium of Atlanta
- Cook County Hosp
- Rush Presbyterian - Saint Luke's Med Ctr
- Tulane Univ / Tulane / LSU Clinical Trials Unit
- New England Med Ctr
- Harvard Univ / Massachusetts Gen Hosp
- Beth Israel Med Ctr
- St Vincents Hosp and Med Ctr / AIDS Cntr Progrm
- Univ of Oklahoma
- Univ of Pennsylvania / Division of Infectious Disease
- Univ of Texas Med Branch
- Infectious Diseases Association of Houston
- Southern Alberta HIV Clinic / Foot Hills Hosp
- Saint Paul's Hosp / Canadian HIV Trials Network
- McMaster Univ Med Ctr
- Montreal Gen Hosp / Div of Clin Immuno and Allergy