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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
ClinicalTrials.gov processed this data on August 23, 2015
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: Endpoint Classification: Safety Study, Primary Purpose: Treatment

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

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, 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

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

Univ of Texas Med Branch, Galveston, Texas 775550835, United States

Infectious Diseases Association of Houston, Houston, Texas 77030, 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.

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

Page last updated: August 23, 2015

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