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 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002162
• Other study ID #: 229D
• Secondary ID: NV15355
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: August 1997
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Saquinavir

• Lamivudine

• Stavudine

• Zidovudine

• Zalcitabine

• Didanosine

Locations

Country	Name	City	State
Canada	Southern Alberta HIV Clinic / Foot Hills Hosp	Calgary	Alberta
Canada	McMaster Univ Med Ctr	Hamilton	Ontario
Canada	Montreal Gen Hosp / Div of Clin Immuno and Allergy	Montreal	Quebec
Canada	Saint Paul's Hosp / Canadian HIV Trials Network	Vancouver	British Columbia
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Harvard Univ / Massachusetts Gen Hosp	Boston	Massachusetts
United States	New England Med Ctr	Boston	Massachusetts
United States	Cook County Hosp	Chicago	Illinois
United States	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois
United States	Univ of Colorado Health Sciences Ctr	Denver	Colorado
United States	Univ of Texas Med Branch	Galveston	Texas
United States	Infectious Diseases Association of Houston	Houston	Texas
United States	UCLA AIDS Clinical Research Ctr / Dept of Medicine	Los Angeles	California
United States	Miami Veterans Administration Med Ctr	Miami	Florida
United States	Tulane Univ / Tulane / LSU Clinical Trials Unit	New Orleans	Louisiana
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	AIDS Research Ctr	Palo Alto	California
United States	Univ of Pennsylvania / Division of Infectious Disease	Philadelphia	Pennsylvania
United States	Phoenix Body Positive	Phoenix	Arizona
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	Saint Joseph's Hosp	Tampa	Florida
United States	Whitman Walker Clinic	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (3)

Cadman J. Roche brings new formulation of saquinavir to FDA. Food and Drug Administration. GMHC Treat Issues. 1997 Apr-May;11(4/5):8. — View Citation

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. — View Citation

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)