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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002162
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 1997
  Purpose

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


Condition Intervention Phase
HIV Infections
Drug: Saquinavir
Drug: Lamivudine
Drug: Stavudine
Drug: Zidovudine
Drug: Zalcitabine
Drug: Didanosine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 140
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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002162

  Hide Study Locations
Locations
United States, Arizona
Phoenix Body Positive
Phoenix, Arizona, United States, 85016
United States, California
UCLA AIDS Clinical Research Ctr / Dept of Medicine
Los Angeles, California, United States, 90024
AIDS Research Ctr
Palo Alto, California, United States, 94304
UCD Med Ctr
Sacramento, California, United States, 95817
UCSD Treatment Ctr
San Diego, California, United States, 921036329
San Francisco Veterans Adm Med Cntr
San Francisco, California, United States, 94121
Mount Zion Hosp of UCSF
San Francisco, California, United States, 94115
United States, Colorado
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
United States, District of Columbia
Whitman Walker Clinic
Washington, District of Columbia, United States, 20009
United States, Florida
Miami Veterans Administration Med Ctr
Miami, Florida, United States, 33125
Saint Joseph's Hosp
Tampa, Florida, United States, 33614
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
Cook County Hosp
Chicago, Illinois, United States, 60612
United States, Louisiana
Tulane Univ / Tulane / LSU Clinical Trials Unit
New Orleans, Louisiana, United States, 70122
United States, Massachusetts
Harvard Univ / Massachusetts Gen Hosp
Boston, Massachusetts, United States, 02114
New England Med Ctr
Boston, Massachusetts, United States, 02111
United States, New York
Beth Israel Med Ctr
New York, New York, United States, 10003
St Vincents Hosp and Med Ctr / AIDS Cntr Progrm
New York, New York, United States, 10011
United States, Oklahoma
Univ of Oklahoma
Oklahoma City, Oklahoma, United States, 73117
United States, Pennsylvania
Univ of Pennsylvania / Division of Infectious Disease
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Univ of Texas Med Branch
Galveston, Texas, United States, 775550835
Infectious Diseases Association of Houston
Houston, Texas, United States, 77030
Canada, Alberta
Southern Alberta HIV Clinic / Foot Hills Hosp
Calgary, Alberta, Canada
Canada, British Columbia
Saint Paul's Hosp / Canadian HIV Trials Network
Vancouver, British Columbia, Canada
Canada, Ontario
McMaster Univ Med Ctr
Hamilton, Ontario, Canada
Canada, Quebec
Montreal Gen Hosp / Div of Clin Immuno and Allergy
Montreal, Quebec, Canada
Sponsors and Collaborators
Hoffmann-La Roche
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00002162     History of Changes
Other Study ID Numbers: 229D, NV15355
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
Saquinavir

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Zalcitabine
Didanosine
Zidovudine
Stavudine
Lamivudine
Saquinavir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
HIV Protease Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014