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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

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Indinavir sulfate (Drug); Lamivudine/Zidovudine (Drug); Hydroxyurea (Drug); Lamivudine (Drug); Stavudine (Drug); Zidovudine (Drug); Didanosine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Havlir D; Richman D, Study Chair
Collier A, Study Chair
Hirsch M, Study Chair
Tebas P, Study Chair

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 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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Primary Purpose: Treatment

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 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

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Alabama Therapeutics CRS, Birmingham, Alabama 35294, United States

Stanford CRS, Palo Alto, California 943055107, United States

Ucsd, Avrc Crs, San Diego, California 921036325, United States

San Mateo County AIDS Program, San Mateo, California 943055107, United States

Harbor-UCLA Med. Ctr. CRS, Torrance, California 90502, United States

University of Colorado Hospital CRS, Aurora, Colorado 80262, United States

Univ. of Miami AIDS CRS, Miami, Florida 331361013, United States

Univ. of Hawaii at Manoa, Leahi Hosp., Honolulu, Hawaii 96816, United States

Northwestern University CRS, Chicago, Illinois 60611, United States

Weiss Memorial Hosp., Chicago, Illinois 60640, United States

Indiana Univ. School of Medicine, Infectious Disease Research Clinic, Indianapolis, Indiana 46202, United States

Indiana Univ. School of Medicine, Wishard Memorial, Indianapolis, Indiana 462025250, United States

Univ. of Iowa Healthcare, Div. of Infectious Diseases, Iowa City, Iowa 52242, United States

Tulane Hemophilia Treatment Ctr., New Orleans, Louisiana 70112, United States

Johns Hopkins Adult AIDS CRS, Baltimore, Maryland 21287, United States

Beth Israel Deaconess Med. Ctr., ACTG CRS, Boston, Massachusetts 02215, United States

Massachusetts General Hospital ACTG CRS, Boston, Massachusetts 02114, United States

University of Minnesota, ACTU, Minneapolis, Minnesota 55455, United States

St. Louis ConnectCare, Infectious Diseases Clinic, St Louis, Missouri 63112, United States

Washington U CRS, St. Louis, Missouri, United States

Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr., Omaha, Nebraska 681985130, United States

Beth Israel Med. Ctr. (Mt. Sinai), New York, New York 10003, United States

Beth Israel Med. Ctr., ACTU, New York, New York, United States

NY Univ. HIV/AIDS CRS, New York, New York 10016, United States

Univ. of Rochester ACTG CRS, Rochester, New York 14642, United States

Unc Aids Crs, Chapel Hill, North Carolina 275997215, United States

Carolinas HealthCare System, Carolinas Med. Ctr., Charlotte, North Carolina 28203, United States

Regional Center for Infectious Disease, Wendover Medical Center CRS, Greensboro, North Carolina 27401, United States

Univ. of Cincinnati CRS, Cincinnati, Ohio 452670405, United States

Case CRS, Cleveland, Ohio 44106, United States

MetroHealth CRS, Cleveland, Ohio 441091998, United States

The Ohio State Univ. AIDS CRS, Columbus, Ohio 432101228, United States

Hosp. of the Univ. of Pennsylvania CRS, Philadelphia, Pennsylvania 19104, United States

University of Washington AIDS CRS, Seattle, Washington 98104, United States

Additional Information

Click here for more information about zidovudine

Click here for more information about didanosine

Click here for more information about stavudine

Click here for more information about lamivudine

Click here for more information about indinavir sulfate

Click here for more information about lamivudine/zidovudine

Haga clic aquí para ver información sobre este ensayo clínico en español.

Related publications:

Havlir DV, Gilbert PB, Bennett K, Collier AC, Hirsch MS, Tebas P, Adams EM, Wheat LJ, Goodwin D, Schnittman S, Holohan MK, Richman DD; ACTG 5025 Study Group. Effects of treatment intensification with hydroxyurea in HIV-infected patients with virologic suppression. AIDS. 2001 Jul 27;15(11):1379-88.


Last updated: May 17, 2012

Page last updated: August 23, 2015

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