Search / Trial NCT00000840

A Multicenter, Exploratory Study to Evaluate the Effects of Antiretroviral Cessation on Plasma Associated HIV-1 RNA

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

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Trial Information

Current as of July 23, 2024

Completed

Keywords

Acquired Immunodeficiency Syndrome Aids Related Complex Antiviral Agents Zidovudine Biological Markers Viremia Rna, Viral

Description

Because viral load (amount of HIV RNA in the plasma) is often used as a measure of the effectiveness of new antiretroviral drugs in clinical trials, a washout period, or cessation of current antiretroviral regimens, is commonly required for study entry to allow for a drug-free steady state of viral load prior to initiation of the new drug. However, the kinetics of the viral rebound following drug withdrawal has not been sufficiently studied, and the proper duration of washout is an estimate. Patients who have volunteered to temporarily cease antiretroviral therapy will be followed during a...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Maintenance therapy for opportunistic infection, provided patient has received at least 1 month of stable therapy prior to study.
  • G-CSF.
  • Patients must have:
  • HIV infection.
  • CD4 count <= 500 cells/mm3.
  • At least 12 months of prior AZT, with 2 months of continuous AZT monotherapy immediately prior to study.
  • The need to discontinue AZT because of drug-related toxicity or unwanted side effects or as an entry requirement for another research study.
  • Consent of parent or guardian if < 18 years old.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Current medical status that is considered unsuitable for study participation.
  • Concurrent Medication:
  • Excluded:
  • Therapy for an acute opportunistic infection.
  • Prior Medication:
  • Excluded within the past 2 months:
  • Antiretrovirals other than AZT.
  • Systemic immunomodulators (e.g., gp120, gp160, IL-2, and interferons).
  • Excluded within the past month:
  • Vaccination.

Attachments

readout_NCT00000840_2024-07-23.pdf

4.5 MB

NCT00000840_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

Columbus, Ohio, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Seattle, Washington, United States

Rochester, New York, United States

Cleveland, Ohio, United States

Baltimore, Maryland, United States

Buffalo, New York, 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
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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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