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NCT00000916 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000916
Other study ID # A5025
Secondary ID 10873ACTG A5025
Status Completed
Phase Phase 2
First received
Last updated
Est. completion date August 2004

Study information
Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 399
Est. completion date August 2004
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 13 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Indinavir sulfate

• Lamivudine/Zidovudine

• Hydroxyurea

• Lamivudine

• Stavudine

• Zidovudine

• Didanosine

Locations
Country Name City State
United States University of Colorado Hospital CRS Aurora Colorado
United States Johns Hopkins Adult AIDS CRS Baltimore Maryland
United States Alabama Therapeutics CRS Birmingham Alabama
United States Beth Israel Deaconess Med. Ctr., ACTG CRS Boston Massachusetts
United States Massachusetts General Hospital ACTG CRS Boston Massachusetts
United States Unc Aids Crs Chapel Hill North Carolina
United States Carolinas HealthCare System, Carolinas Med. Ctr. Charlotte North Carolina
United States Northwestern University CRS Chicago Illinois
United States Weiss Memorial Hosp. Chicago Illinois
United States Univ. of Cincinnati CRS Cincinnati Ohio
United States Case CRS Cleveland Ohio
United States MetroHealth CRS Cleveland Ohio
United States The Ohio State Univ. AIDS CRS Columbus Ohio
United States Regional Center for Infectious Disease, Wendover Medical Center CRS Greensboro North Carolina
United States Univ. of Hawaii at Manoa, Leahi Hosp. Honolulu Hawaii
United States Indiana Univ. School of Medicine, Infectious Disease Research Clinic Indianapolis Indiana
United States Indiana Univ. School of Medicine, Wishard Memorial Indianapolis Indiana
United States Univ. of Iowa Healthcare, Div. of Infectious Diseases Iowa City Iowa
United States Univ. of Miami AIDS CRS Miami Florida
United States University of Minnesota, ACTU Minneapolis Minnesota
United States Tulane Hemophilia Treatment Ctr. New Orleans Louisiana
United States Beth Israel Med. Ctr. (Mt. Sinai) New York New York
United States Beth Israel Med. Ctr., ACTU New York New York
United States NY Univ. HIV/AIDS CRS New York New York
United States Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr. Omaha Nebraska
United States Stanford CRS Palo Alto California
United States Hosp. of the Univ. of Pennsylvania CRS Philadelphia Pennsylvania
United States Univ. of Rochester ACTG CRS Rochester New York
United States St. Louis ConnectCare, Infectious Diseases Clinic Saint Louis Missouri
United States Washington U CRS Saint Louis Missouri
United States Ucsd, Avrc Crs San Diego California
United States San Mateo County AIDS Program San Mateo California
United States University of Washington AIDS CRS Seattle Washington
United States Harbor-UCLA Med. Ctr. CRS Torrance California

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

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