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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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

Key facts

Study ID

NCT00002162

Run by

Hoffmann-La Roche

People needed

140

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Phoenix Body Positive — Phoenix, Arizona, United States
• UCLA AIDS Clinical Research Ctr / Dept of Medicine — Los Angeles, California, United States
• AIDS Research Ctr — Palo Alto, California, United States
• UCD Med Ctr — Sacramento, California, United States
• UCSD Treatment Ctr — San Diego, California, United States
• Mount Zion Hosp of UCSF — San Francisco, California, United States
• San Francisco Veterans Adm Med Cntr — San Francisco, California, United States
• Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
• Whitman Walker Clinic — Washington D.C., District of Columbia, United States
• Miami Veterans Administration Med Ctr — Miami, Florida, United States
• Saint Joseph's Hosp — Tampa, Florida, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• Cook County Hosp — Chicago, Illinois, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Tulane Univ / Tulane / LSU Clinical Trials Unit — New Orleans, Louisiana, United States
• New England Med Ctr — Boston, Massachusetts, United States
• Harvard Univ / Massachusetts Gen Hosp — Boston, Massachusetts, United States
• Beth Israel Med Ctr — New York, New York, United States
• St Vincents Hosp and Med Ctr / AIDS Cntr Progrm — New York, New York, United States
• Univ of Oklahoma — Oklahoma City, Oklahoma, United States
• Univ of Pennsylvania / Division of Infectious Disease — Philadelphia, Pennsylvania, United States
• Univ of Texas Med Branch — Galveston, Texas, United States
• Infectious Diseases Association of Houston — Houston, Texas, United States
• Southern Alberta HIV Clinic / Foot Hills Hosp — Calgary, Alberta, Canada
• Saint Paul's Hosp / Canadian HIV Trials Network — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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