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.
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.
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.
Univ of Alabama at Birmingham, Birmingham, Alabama 35294, United States
Univ of California / San Diego Treatment Ctr, San Diego, California 921036325, United States
Stanford Univ Med Ctr, Stanford, California 943055107, United States
Harbor UCLA Med Ctr, Torrance, California 90502, United States
San Mateo AIDS Program / Stanford Univ, Stanford, California 943055107, United States
Willow Clinic, Menlo Park, California 94025, United States
Univ of Colorado Health Sciences Ctr, Denver, Colorado 80262, United States
Univ of Miami School of Medicine, Miami, Florida 331361013, United States
Univ of Hawaii, Honolulu, Hawaii 96816, United States
Northwestern Univ Med School, Chicago, Illinois 60611, United States
Louis A Weiss Memorial Hosp, Chicago, Illinois 60640, United States
Indiana Univ Hosp, Indianapolis, Indiana 462025250, United States
Division of Inf Diseases/ Indiana Univ Hosp, Indianapolis, Indiana 46202, United States
Univ of Iowa Hosp and Clinic, Iowa City, Iowa 52242, United States
Tulane Univ School of Medicine, New Orleans, Louisiana 70112, United States
Johns Hopkins Hosp, Baltimore, Maryland 21287, United States
State of MD Div of Corrections / Johns Hopkins Univ Hosp, Baltimore, Maryland 212052196, United States
Harvard (Massachusetts Gen Hosp), Boston, Massachusetts 02114, United States
Beth Israel Deaconess - West Campus, Boston, Massachusetts 02215, United States
Univ of Minnesota, Minneapolis, Minnesota 55455, United States
St Louis Regional Hosp / St Louis Regional Med Ctr, St Louis, Missouri 63112, United States
Univ of Nebraska Med Ctr, Omaha, Nebraska 681985130, United States
Univ of Rochester Medical Center, Rochester, New York 14642, United States
Bellevue Hosp / New York Univ Med Ctr, New York, New York 10016, United States
Beth Israel Med Ctr, New York, New York 10003, United States
Carolinas Med Ctr, Charlotte, North Carolina 28203, United States
Univ of North Carolina, Chapel Hill, North Carolina 275997215, United States
Moses H Cone Memorial Hosp, Greensboro, North Carolina 27401, United States
Case Western Reserve Univ, Cleveland, Ohio 44106, United States
Univ of Cincinnati, Cincinnati, Ohio 452670405, United States
Ohio State Univ Hosp Clinic, Columbus, Ohio 432101228, United States
MetroHealth Med Ctr, Cleveland, Ohio 441091998, United States
Univ of Pennsylvania at Philadelphia, Philadelphia, Pennsylvania 19104, United States
Julio Arroyo, West Columbia, South Carolina 29169, United States
Univ of Texas Galveston, Galveston, Texas 775550435, United States
Univ of Washington, Seattle, Washington 98104, United States
Havlir DV, Gilbert PB, Bennett K, Collier AC, Hirsch MS, Tebas P, Adams EM, Wheat LJ, Goodwin D, Schnittman S, Holohan MK, Richman DD. Effects of treatment intensification with hydroxyurea in HIV-infected patients with virologic suppression. AIDS. 2001 Jul 27;15(11):1379-88.
