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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 Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about 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 conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. 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 Clinical research trials and 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 healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as 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. 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 Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a 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 clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their 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 condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.

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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



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

For Condition: HIV Infections
Status: Terminated
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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 medication changes, including the addition of hydroxyurea (HU), on long-term viral suppression. Other medications which may be added include didanosine (ddI) and/or stavudine (d4T). Patients receiving combination antiretroviral therapy with indinavir (IDV), zidovudine (ZDV)(or d4T) and lamivudine (3TC) show viral suppression for two years or more. Discontinuation of one or two of these drugs results in prompt loss of the viral suppression. Other studies show that addition of HU to some reverse transcriptase inhibitor treatments results in increased antiviral effects. This study will provide further information on the effect of adding HU to a treatment regimen with respect to long-term viral suppression.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 399

Location and Contact Information:

Overall Study Official:
HavlirRichman D,  Study Chair, 

Johns Hopkins Hosp
Baltimore,  Maryland,  21287
United States
 

Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis,  Indiana,  46202
United States
 

Ohio State Univ Hosp Clinic
Columbus,  Ohio,  432101228
United States
 

Univ of Iowa Hosp and Clinic
Iowa City,  Iowa,  52242
United States
 

Univ of Nebraska Med Ctr
Omaha,  Nebraska,  681985130
United States
 

Univ of Washington
Seattle,  Washington,  98104
United States
 

Julio Arroyo
West Columbia,  South Carolina,  29169
United States
 

Willow Clinic
Menlo Park,  California,  94025
United States
 

MetroHealth Med Ctr
Cleveland,  Ohio,  441091998
United States
 

Moses H Cone Memorial Hosp
Greensboro,  North Carolina,  27401
United States
 

Bellevue Hosp / New York Univ Med Ctr
New York City,  New York,  10016
United States
 

Univ of Pennsylvania at Philadelphia
Philadelphia,  Pennsylvania,  19104
United States
 

Harbor UCLA Med Ctr
Torrance,  California,  90502
United States
 

Univ of Alabama at Birmingham
Birmingham,  Alabama,  35294
United States
 

Univ of Minnesota
Minneapolis,  Minnesota,  55455
United States
 

Louis A Weiss Memorial Hosp
Chicago,  Illinois,  60640
United States
 

Univ of Rochester Medical Center
Rochester,  New York,  14642
United States
 

Univ of Miami School of Medicine
Miami,  Florida,  331361013
United States
 

Beth Israel Deaconess - West Campus
Boston,  Massachusetts,  02215
United States
 

Univ of Hawaii
Honolulu,  Hawaii,  96816
United States
 

Univ of California / San Diego Treatment Ctr
San Diego,  California,  921036325
United States
 

Case Western Reserve Univ
Cleveland,  Ohio,  44106
United States
 

Harvard (Massachusetts Gen Hosp)
Boston,  Massachusetts,  02114
United States
 

State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore,  Maryland,  212052196
United States
 

Univ of North Carolina
Chapel Hill,  North Carolina,  275997215
United States
 

San Mateo AIDS Program / Stanford Univ
Stanford,  California,  943055107
United States
 

Univ of Texas Galveston
Galveston,  Texas,  775550435
United States
 

Northwestern Univ Med School
Chicago,  Illinois,  60611
United States
 

Univ of Colorado Health Sciences Ctr
Denver,  Colorado,  80262
United States
 

St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis,  Missouri,  63112
United States
 

Stanford Univ Med Ctr
Stanford,  California,  943055107
United States
 

Tulane Univ School of Medicine
New Orleans,  Louisiana,  70112
United States
 

Beth Israel Med Ctr
New York City,  New York,  10003
United States
 

Indiana Univ Hosp
Indianapolis,  Indiana,  462025250
United States
 

Carolinas Med Ctr
Charlotte,  North Carolina,  28203
United States
 

Univ of Cincinnati
Cincinnati,  Ohio,  452670405
United States
 


Additional Information:
Study ID Numbers:
  ACTG A5025; 
Study Start Date: 
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000916

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