Search / Trial NCT00000861

The Addition of Indinavir to Anti-HIV Treatment in HIV-Infected Patients

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of July 14, 2024

Completed

Keywords

Drug Administration Schedule Hiv Protease Inhibitors Cd4 Lymphocyte Count Indinavir Rna, Viral Anti Hiv Agents Viral Load

Description

This study aims to examine two management strategies, immediate versus deferred IDV therapy, for their clinical effects in the context of background antiretroviral (AR) therapy, given according to current clinical practice. There is an urgent need to identify the optimal use of IDV in patient management, since clinical endpoint studies have not been completed in the United States. Since there is little information about the long term durability of clinical effects, and even less information about the timing of the initiation of protease inhibitor therapy, exploring the disease progression a...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Topical and/or antifungal agents, except ketoconazole.
  • Treatment, maintenance, or chemoprophylaxis with approved agents for OIs will be given as clinically indicated.
  • Clinically indicated antibiotics, unless excluded.
  • Systemic corticosteroid use for <21 days for acute problems is permitted as clinically indicated. However, chronic systemic corticosteroid use should be avoided.
  • Recombinant erythropoietin (rEPO) and granulocyte-colony stimulating factor (G-CSF, filgrastim).
  • Didanosine (ddI).
  • Regularly prescribed medications, such as antipyretics, antidepressants, oral contraceptives, megestrol acetate, testosterone, or any other medication.
  • Patients must have:
  • A working diagnosis of HIV infection.
  • A CD4+ count between 200 and 500 cells/mm3.
  • Signed, informed parental consent if patient is less than 18.
  • NOTE:
  • The DAIDS Clinical Science Research Committee (CSRC) has deemed this protocol appropriate for prisoner enrollment.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with any of the following conditions or symptoms are excluded:
  • Febrile illness with temperature > 38.5 degrees C (101.3 degrees F) within 3 days prior to study entry.
  • Concurrent Medication:
  • Excluded:
  • Non-nucleoside reverse transcriptase inhibitors.
  • Protease inhibitors except IDV.
  • Rifabutin and rifampin.
  • Ketoconazole.
  • Terfenadine, astemizole, cisapride, triazolam and midazolam.
  • Patients with any of the following prior conditions are excluded:
  • History of prior saquinavir (SQV) therapy for more than 14 days.
  • History of any prior protease inhibitor therapy other than SQV.
  • History of serious opportunistic infection.

Attachments

readout_NCT00000861_2024-07-14.pdf

4.5 MB

NCT00000861_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Denver, Colorado, United States

Washington, District Of Columbia, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

New Orleans, Louisiana, United States

Detroit, Michigan, United States

Detroit, Michigan, United States

Camden, New Jersey, United States

Newark, New Jersey, United States

New York, New York, United States

Philadelphia, Pennsylvania, United States

Richmond, Virginia, United States

San Francisco, California, United States

Portland, Oregon, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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