Status:
COMPLETED
A Study of the Safety and Effectiveness of Hydroxyurea in Patients on Potent Antiretroviral Therapy and Who Have Less Than 200 Copies/ml of HIV RNA in Their Blood
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
13+ years
Phase:
PHASE2
Brief Summary
This study compares the safety and effectiveness of continuing your current anti-HIV medications to that of adding or switching some of your anti-HIV medications. It will follow the effect of these me...
Detailed Description
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 whet...
Eligibility 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
August 1 2004
Estimated Enrollment :
399 Patients enrolled
Trial Details
Trial ID
NCT00000916
End Date
August 1 2004
Last Update
October 29 2021
Active Locations (34)
Enter a location and click search to find clinical trials sorted by distance.
1
Alabama Therapeutics CRS
Birmingham, Alabama, United States, 35294
2
Stanford CRS
Palo Alto, California, United States, 943055107
3
Ucsd, Avrc Crs
San Diego, California, United States, 921036325
4
San Mateo County AIDS Program
San Mateo, California, United States, 943055107