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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000840
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 2000

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00000840 on ClinicalTrials.gov Archive Site
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A Multicenter, Exploratory Study to Evaluate the Effects of Antiretroviral Cessation on Plasma Associated HIV-1 RNA
A Multicenter, Exploratory Study to Evaluate the Effects of Antiretroviral Cessation on Plasma Associated HIV-1 RNA

To evaluate viral load in the blood stream of HIV-infected patients during a 28-day washout following cessation of long-term zidovudine ( AZT ) therapy.

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.

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 28-day washout period. Blood samples are drawn at each of nine clinic visits. Patients may resume antiretrovirals after the 28-day washout.

Observational
Observational Model: Natural History
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HIV Infections
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
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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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000840
ACTG 304
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National Institute of Allergy and Infectious Diseases (NIAID)
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Study Chair: Para MF
Study Chair: Demeter L
National Institute of Allergy and Infectious Diseases (NIAID)
April 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP