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
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Saquinavir (Drug); Lamivudine (Drug); Stavudine (Drug); Zidovudine (Drug); Zalcitabine (Drug); Didanosine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Hoffmann-La Roche
Summary
To evaluate the antiviral activity and safety of two formulations of saquinavir in
combination with licensed nucleoside antiretroviral drugs.
Clinical Details
Official title: 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
Study design: Treatment, Safety Study
Detailed description:
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.
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): 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.
Locations and Contacts
Southern Alberta HIV Clinic / Foot Hills Hosp, Calgary, Alberta, Canada
Phoenix Body Positive, Phoenix, Arizona 85016, United States
Saint Paul's Hosp / Canadian HIV Trials Network, Vancouver, British Columbia, Canada
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
Univ of Colorado Health Sciences Ctr, Denver, Colorado 80262, United States
Whitman Walker Clinic, Washington, 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
Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois 60612, United States
Cook County Hosp, Chicago, Illinois 60612, United States
Tulane Univ / Tulane / LSU Clinical Trials Unit, New Orleans, Louisiana 70122, United States
Harvard Univ / Massachusetts Gen Hosp, Boston, Massachusetts 02114, United States
New England Med Ctr, Boston, Massachusetts 02111, 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
McMaster Univ Med Ctr, Hamilton, Ontario, Canada
Univ of Pennsylvania / Division of Infectious Disease, Philadelphia, Pennsylvania 19104, United States
Montreal Gen Hosp / Div of Clin Immuno and Allergy, Montreal, Quebec, Canada
Infectious Diseases Association of Houston, Houston, Texas 77030, United States
Univ of Texas Med Branch, Galveston, Texas 775550835, United States
Additional Information
Related publications: Cadman J. Roche brings new formulation of saquinavir to FDA. Food and Drug Administration. GMHC Treat Issues. 1997 Apr-May;11(4/5):8. No abstract available. Thompson M. Activity of soft gelatin capsule formulation of saquinavir in combination with two nucleosides in treatment-naive HIV-1-seropositive persons. The NV15355 Study Team. Int Conf AIDS. 1998;12:40 (abstract no 12145) Mitsuyasu 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.
Last updated: June 23, 2005
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