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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by (Responsible Party): | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000848 |
Purpose
To determine, in HIV-infected patients, whether switching to a new soft gelatin capsule formulation of saquinavir or to indinavir following prolonged use of the original hard capsule formulation of saquinavir results in an acute decrease in plasma HIV RNA.
Resistance to anti-HIV agents occurs with increasing duration of use. In vitro studies have shown that cross-resistance occurs among protease inhibitors, although no clinical trials have been conducted to examine antiretroviral activity with sequential use of protease inhibitors or to determine whether saquinavir resistance can be overcome with higher concentrations of the drug.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Indinavir sulfate Drug: Saquinavir |
Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | The Antiviral Effect of Switching From Hard Capsule Saquinavir (SQVhc) to the Soft Gelatin Capsule of Saquinavir (SQVsc) Versus Switching to Indinavir (IDV) After 1 Year of Saquinavir Use |
| Estimated Enrollment: | 144 |
| Study Completion Date: | October 1998 |
Resistance to anti-HIV agents occurs with increasing duration of use. In vitro studies have shown that cross-resistance occurs among protease inhibitors, although no clinical trials have been conducted to examine antiretroviral activity with sequential use of protease inhibitors or to determine whether saquinavir resistance can be overcome with higher concentrations of the drug.
Patients who are currently receiving hard capsule saquinavir are randomized to continue receiving hard capsule saquinavir or to switch to soft gelatin capsule saquinavir or indinavir. At week 8, patients receiving the hard capsule formulation will switch to open-label indinavir for weeks 8-24. Patients on the other two arms will remain on their assigned regimen for the entire 24 weeks unless they have no virologic response by week 8, in which case they will be crossed-over to open-label therapy with the alternative drug (i.e., either soft gelatin capsule saquinavir or indinavir).
AS PER AMENDMENT 12/23/96: Viral RNA from weeks 16 and 24 will be assayed in batch after week 24. Patients who exhibit an antiviral response based on this assay will be allowed to continue their current drug assignment for a total of 12 months.
AS PER AMENDMENT 5/7/97: Based on an interim analysis performed after 72 patients had completed 8 weeks of therapy, the study was closed as of March 7, 1997. Patients currently enrolled may stop their participation in the trial and seek other anti-retroviral therapies or may continue on study. Patients on hard capsule saquinavir who remain on study will be switched to indinavir at 8 weeks. Patients on soft gel capsule saquinavir may switch immediately to indinavir or, when results of HIV RNA and CD4 cell counts are available, may choose to switch to indinavir or remain on soft gel capsule saquinavir. Patients receiving indinavir will continue that agent. Follow-up for all patients will end on 7/4/97.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Required:
Allowed:
Concurrent Treatment:
Allowed:
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
AS PER AMENDMENT 5/7/97:
Concurrent Medication:
Excluded:
AS PER AMENDMENT 5/7/97:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Excluded within the past 2 months.
Excluded within the past month:
Excluded within the past 2 weeks:
Active substance abuse that would interfere with study evaluation or procedures.
Contacts and Locations| United States, California | |
| Stanford CRS | |
| Palo Alto, California, United States, 94304 | |
| Ucsf Aids Crs | |
| San Francisco, California, United States, 94110 | |
| Harbor-UCLA Med. Ctr. CRS | |
| Torrance, California, United States, 90502 | |
| United States, Colorado | |
| University of Colorado Hospital CRS | |
| Aurora, Colorado, United States, 80045 | |
| United States, Florida | |
| Univ. of Miami AIDS CRS | |
| Miami, Florida, United States, 33136 | |
| United States, Illinois | |
| Northwestern University CRS | |
| Chicago, Illinois, United States, 60611 | |
| Rush Univ. Med. Ctr. ACTG CRS | |
| Chicago, Illinois, United States, 60612 | |
| United States, Massachusetts | |
| Massachusetts General Hospital ACTG CRS | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Missouri | |
| St. Louis ConnectCare, Infectious Diseases Clinic | |
| St. Louis, Missouri, United States, 63112 | |
| Washington U CRS | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| SUNY - Buffalo, Erie County Medical Ctr. | |
| Buffalo, New York, United States, 14260 | |
| NY Univ. HIV/AIDS CRS | |
| New York, New York, United States, 10016 | |
| Beth Israel Med. Ctr. (Mt. Sinai) | |
| New York, New York, United States, 10003 | |
| Univ. of Rochester ACTG CRS | |
| Rochester, New York, United States, 14642 | |
| United States, Ohio | |
| The Ohio State Univ. AIDS CRS | |
| Columbus, Ohio, United States, 43210 | |
| United States, Washington | |
| University of Washington AIDS CRS | |
| Seattle, Washington, United States, 98104 | |
| Study Chair: | Para MF | |
| Study Chair: | Collier A | |
| Study Chair: | Coombs R |
More Information
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000848 History of Changes |
| Other Study ID Numbers: | ACTG 333, 11305 |
| Study First Received: | November 2, 1999 |
| Last Updated: | February 13, 2012 |
| Health Authority: | United States: Federal Government |
|
Administration, Oral Acquired Immunodeficiency Syndrome AIDS-Related Complex Antiviral Agents HIV Protease Inhibitors |
Biological Markers Indinavir Viremia RNA, Viral Saquinavir |
|
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 Antiviral Agents |
Indinavir Saquinavir HIV Protease Inhibitors Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents |