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Home > "A" Clinical Trials Conditions > 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
A Multicenter, Exploratory Study to Evaluate the Effects of Antiretroviral Cessation on Plasma Associated HIV-1 RNA
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 70
Location and Contact Information:
Overall Study Official:
ParaMF, Study Chair,
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Univ of Washington
Seattle, Washington, 981224304
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Additional Information:
Study ID Numbers: ACTG 304;
Study Start Date:
Record last reviewed: April 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000840
Other Hiv Infections Studies:
1. Dehydroepiandrosterone Effects on HIV-1 Replication
2. Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors
3. A Phase I Study of Recombinant CD4(rCD4) in Patients With AIDS and AIDS-Related Complex
4. A Study of Spiramycin in the Treatment of Patients with AIDS-Related Diarrhea
5. HIV Prevention Counseling for Men Who Have Sex with Men
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A Multicenter, Exploratory Study to Evaluate the Effects of Antiretroviral Cessation on Plasma Associated HIV-1 RNA
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