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

NCT00000916 | Completed Phase 2

• 3 other identifiers: A502510873ACTG A5025
• Study Type: interventional
• Target: 399
• Locations: 1 country
• Sites: 34

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 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.

Conditions

HIV Infections

Keywords

Drug Therapy, Combination; HIV Protease Inhibitors; Hydroxyurea; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Viral Load

Interventions

Indinavir sulfate DRUG

Lamivudine/Zidovudine DRUG

Hydroxyurea DRUG

Lamivudine DRUG

Stavudine DRUG

Zidovudine DRUG

Didanosine DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (34)

Alabama Therapeutics CRS

Birmingham, Alabama, 35294, United States

Location

Stanford CRS

Palo Alto, California, 943055107, United States

Location

Ucsd, Avrc Crs

San Diego, California, 921036325, United States

Location

San Mateo County AIDS Program

San Mateo, California, 943055107, United States

Location

Harbor-UCLA Med. Ctr. CRS

Torrance, California, 90502, United States

Location

University of Colorado Hospital CRS

Aurora, Colorado, 80262, United States

Location

Univ. of Miami AIDS CRS

Miami, Florida, 331361013, United States

Location

Univ. of Hawaii at Manoa, Leahi Hosp.

Honolulu, Hawaii, 96816, United States

Location

Northwestern University CRS

Chicago, Illinois, 60611, United States

Location

Weiss Memorial Hosp.

Chicago, Illinois, 60640, United States

Location

Indiana Univ. School of Medicine, Wishard Memorial

Indianapolis, Indiana, 462025250, United States

Location

Indiana Univ. School of Medicine, Infectious Disease Research Clinic

Indianapolis, Indiana, 46202, United States

Location

Univ. of Iowa Healthcare, Div. of Infectious Diseases

Iowa City, Iowa, 52242, United States

Location

Tulane Hemophilia Treatment Ctr.

New Orleans, Louisiana, 70112, United States

Location

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital ACTG CRS

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Med. Ctr., ACTG CRS

Boston, Massachusetts, 02215, United States

Location

University of Minnesota, ACTU

Minneapolis, Minnesota, 55455, United States

Location

St. Louis ConnectCare, Infectious Diseases Clinic

St Louis, Missouri, 63112, United States

Location

Washington U CRS

St Louis, Missouri, United States

Location

Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.

Omaha, Nebraska, 681985130, United States

Location

Beth Israel Med. Ctr. (Mt. Sinai)

New York, New York, 10003, United States

Location

NY Univ. HIV/AIDS CRS

New York, New York, 10016, United States

Location

Beth Israel Med. Ctr., ACTU

New York, New York, United States

Location

Univ. of Rochester ACTG CRS

Rochester, New York, 14642, United States

Location

Unc Aids Crs

Chapel Hill, North Carolina, 275997215, United States

Location

Carolinas HealthCare System, Carolinas Med. Ctr.

Charlotte, North Carolina, 28203, United States

Location

Regional Center for Infectious Disease, Wendover Medical Center CRS

Greensboro, North Carolina, 27401, United States

Location

Univ. of Cincinnati CRS

Cincinnati, Ohio, 452670405, United States

Location

Case CRS

Cleveland, Ohio, 44106, United States

Location

MetroHealth CRS

Cleveland, Ohio, 441091998, United States

Location

The Ohio State Univ. AIDS CRS

Columbus, Ohio, 432101228, United States

Location

Hosp. of the Univ. of Pennsylvania CRS

Philadelphia, Pennsylvania, 19104, United States

Location

University of Washington AIDS CRS

Seattle, Washington, 98104, United States

Location

Related 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. doi: 10.1097/00002030-200107270-00007.

  PMID: 11504959 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Indinavir; lamivudine, zidovudine drug combination; Hydroxyurea; Lamivudine; Stavudine; Zidovudine; Didanosine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Urea; Amides; Organic Chemicals; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Thymidine; Inosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ribonucleosides

Study Officials

• Havlir D; Richman D

  STUDY CHAIR

• Collier A

  STUDY CHAIR

• Hirsch M

  STUDY CHAIR

• Tebas P

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: August 1, 2004
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

US (34)