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
2 other identifiers
interventional
140
2 countries
27
Brief Summary
To evaluate the antiviral activity and safety of two formulations of saquinavir in combination with licensed nucleoside antiretroviral drugs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hiv-infections
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
August 1, 1997
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Phoenix Body Positive
Phoenix, Arizona, 85016, United States
UCLA AIDS Clinical Research Ctr / Dept of Medicine
Los Angeles, California, 90024, United States
AIDS Research Ctr
Palo Alto, California, 94304, United States
UCD Med Ctr
Sacramento, California, 95817, United States
UCSD Treatment Ctr
San Diego, California, 921036329, United States
Mount Zion Hosp of UCSF
San Francisco, California, 94115, United States
San Francisco Veterans Adm Med Cntr
San Francisco, California, 94121, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Whitman Walker Clinic
Washington D.C., District of Columbia, 20009, United States
Miami Veterans Administration Med Ctr
Miami, Florida, 33125, United States
Saint Joseph's Hosp
Tampa, Florida, 33614, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Cook County Hosp
Chicago, Illinois, 60612, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Tulane Univ / Tulane / LSU Clinical Trials Unit
New Orleans, Louisiana, 70122, United States
New England Med Ctr
Boston, Massachusetts, 02111, United States
Harvard Univ / Massachusetts Gen Hosp
Boston, Massachusetts, 02114, United States
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
Univ of Oklahoma
Oklahoma City, Oklahoma, 73117, United States
Univ of Pennsylvania / Division of Infectious Disease
Philadelphia, Pennsylvania, 19104, United States
Univ of Texas Med Branch
Galveston, Texas, 775550835, United States
Infectious Diseases Association of Houston
Houston, Texas, 77030, United States
Southern Alberta HIV Clinic / Foot Hills Hosp
Calgary, Alberta, Canada
Saint Paul's Hosp / Canadian HIV Trials Network
Vancouver, British Columbia, Canada
McMaster Univ Med Ctr
Hamilton, Ontario, Canada
Montreal Gen Hosp / Div of Clin Immuno and Allergy
Montreal, Quebec, Canada
Related Publications (2)
Cadman J. Roche brings new formulation of saquinavir to FDA. Food and Drug Administration. GMHC Treat Issues. 1997 Apr-May;11(4/5):8.
PMID: 11364377BACKGROUNDMitsuyasu RT, Skolnik PR, Cohen SR, Conway B, Gill MJ, Jensen PC, Pulvirenti JJ, Slater LN, Schooley RT, Thompson MA, Torres RA, Tsoukas CM. Activity of the soft gelatin formulation of saquinavir in combination therapy in antiretroviral-naive patients. NV15355 Study Team. AIDS. 1998 Jul 30;12(11):F103-9. doi: 10.1097/00002030-199811000-00001.
PMID: 9708399BACKGROUND