Clinical trial NCT00002162: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
Saquinavir
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 140
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Body Positive
state: Arizona
city: Los Angeles
country: United States
facility: UCLA AIDS Clinical Research Ctr / Dept of Medicine
state: California
city: Palo Alto
country: United States
facility: AIDS Research Ctr
state: California
city: Sacramento
country: United States
facility: UCD Med Ctr
state: California
city: San Diego
country: United States
facility: UCSD Treatment Ctr
state: California
city: San Francisco
country: United States
facility: Mount Zion Hosp of UCSF
state: California
city: San Francisco
country: United States
facility: San Francisco Veterans Adm Med Cntr
state: California
city: Denver
country: United States
facility: Univ of Colorado Health Sciences Ctr
state: Colorado
city: Washington
country: United States
facility: Whitman Walker Clinic
state: District of Columbia
city: Miami
country: United States
facility: Miami Veterans Administration Med Ctr
state: Florida
city: Tampa
country: United States
facility: Saint Joseph's Hosp
state: Florida
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Cook County Hosp
state: Illinois
city: Chicago
country: United States
facility: Rush Presbyterian - Saint Luke's Med Ctr
state: Illinois
city: New Orleans
country: United States
facility: Tulane Univ / Tulane / LSU Clinical Trials Unit
state: Louisiana
city: Boston
country: United States
facility: New England Med Ctr
state: Massachusetts
city: Boston
country: United States
facility: Harvard Univ / Massachusetts Gen Hosp
state: Massachusetts
city: New York
country: United States
facility: Beth Israel Med Ctr
state: New York
city: New York
country: United States
facility: St Vincents Hosp and Med Ctr / AIDS Cntr Progrm
state: New York
city: Oklahoma City
country: United States
facility: Univ of Oklahoma
state: Oklahoma
city: Philadelphia
country: United States
facility: Univ of Pennsylvania / Division of Infectious Disease
state: Pennsylvania
city: Galveston
country: United States
facility: Univ of Texas Med Branch
state: Texas
city: Houston
country: United States
facility: Infectious Diseases Association of Houston
state: Texas
city: Calgary
country: Canada
facility: Southern Alberta HIV Clinic / Foot Hills Hosp
state: Alberta
city: Vancouver
country: Canada
facility: Saint Paul's Hosp / Canadian HIV Trials Network
state: British Columbia
city: Hamilton
country: Canada
facility: McMaster Univ Med Ctr
state: Ontario
city: Montreal
country: Canada
facility: Montreal Gen Hosp / Div of Clin Immuno and Allergy
state: Quebec
Study officials:
References:
citation: Cadman J. Roche brings new formulation of saquinavir to FDA. Food and Drug Administration. GMHC Treat Issues. 1997 Apr-May;11(4/5):8.
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. doi: 10.1097/00002030-199811000-00001.