Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

HIV Infections

Eligibility:

All Genders

13+ years

Brief Summary

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 p...

Detailed 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 antiretro...

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.

Key Trial Info

Start Date :

Trial Type :

OBSERVATIONAL

End Date :

Estimated Enrollment :

70 Patients enrolled

Trial Details

Trial ID

NCT00000840

Last Update

June 24 2005

Active Locations (8)

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Page 1 of 2 (8 locations)

1

Northwestern Univ Med School

Chicago, Illinois, United States, 60611

2

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, United States, 60612

3

Johns Hopkins Hosp

Baltimore, Maryland, United States, 21287

4

SUNY / Erie County Med Ctr at Buffalo

Buffalo, New York, United States, 14215