A Phase II, Randomized Study of the Safety and Efficacy of Hydroxyurea in Subjects on Potent Antiretroviral Therapy With Less Than 200 Copies/ml of HIV RNA in the Plasma
Data Collection
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Previous ACTG studies show that discontinuation of one or two of a three-drug regimen (IDV, ZDV, 3TC) leads to prompt loss of viral suppression in the plasma. In this trial, it will be determined whether adding hydroxyurea (HU) to a suppressive regimen increases long term viral suppression. Important safety information on the tolerance of HU regimen will be characterized in asymptomatic patients with viral suppression. Patients are equally randomized to one of three arms and receive treatment as follows:Arm A: IDV plus ddI plus d4T plus HU placebo. Arm B: IDV plus ddI plus d4T plus HU. Arm C: IDV plus 3TC/ZDV (or d4T plus 3TC). Patients are monitored every 8 weeks with plasma HIV RNA levels and CD4 cell counts.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.399 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 13 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria You may be eligible for this study if you: * Are 13 years or older. * Have documented HIV-1 infection. * Are currently receiving combined IDV, ZDV(or D4T), and 3TC for at least 6 consecutive months, resulting in HIV RNA less than 200 copies/ml and CD4 cell count greater than 200 cells/mm3. * Had a CD4 count greater than 100 cells/mm3 before starting current anti-HIV therapy. * Are of childbearing age and agree to practice abstinence or use of combined barrier and hormonal methods of birth control during and for 3 months after the study. Exclusion Criteria You will not be eligible for this study if you: * Have taken various medications and have various laboratory results (see technical abstract). * Have cancer requiring chemotherapy. * Have an unexplained fever for 7 days or diarrhea for 15 days in the month before the start of the study. * Had prior peripheral neuropathy or hepatitis. * Recently underwent radiation, experimental, or infection therapy. * Are pregnant or breastfeeding.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 34 locations
Stanford CRS
Palo Alto, United StatesUcsd, Avrc Crs
San Diego, United StatesSan Mateo County AIDS Program
San Mateo, United States