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| Sponsor: | Hoffmann-La Roche |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002162 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| 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 |
| Estimated Enrollment: | 140 |
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 |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Phoenix Body Positive | |
| Phoenix, Arizona, United States, 85016 | |
| United States, California | |
| UCD Med Ctr | |
| Sacramento, California, United States, 95817 | |
| San Francisco Veterans Adm Med Cntr | |
| San Francisco, California, United States, 94121 | |
| AIDS Research Ctr | |
| Palo Alto, California, United States, 94304 | |
| Mount Zion Hosp of UCSF | |
| San Francisco, California, United States, 94115 | |
| UCSD Treatment Ctr | |
| San Diego, California, United States, 921036329 | |
| UCLA AIDS Clinical Research Ctr / Dept of Medicine | |
| Los Angeles, California, United States, 90024 | |
| 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 | |
| Infectious Diseases Association of Houston | |
| Houston, Texas, United States, 77030 | |
| Univ of Texas Med Branch | |
| Galveston, Texas, United States, 775550835 | |
| 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 | |
More Information
| Study ID Numbers: | 229D, NV15355 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002162 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex Antiviral Agents Saquinavir |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Stavudine Molecular Mechanisms of Pharmacological Action Saquinavir Zidovudine Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Zalcitabine Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases Didanosine HIV Infections Sexually Transmitted Diseases |