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

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00000916
• Collaborator: (none)
• Enrollment: 399
• Locations: 34
• Patients Per Site: 11.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Indinavir sulfate; Drug: Lamivudine/Zidovudine; Drug: Hydroxyurea; Drug: Lamivudine; Drug: Stavudine; Drug: Zidovudine; Drug: Didanosine	Phase 2

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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Primary Purpose: Treatment
• 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
• Actual Study Completion Date: Aug 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alabama Therapeutics CRS	Birmingham	Alabama	United States	35294
2	Stanford CRS	Palo Alto	California	United States	943055107
3	Ucsd, Avrc Crs	San Diego	California	United States	921036325
4	San Mateo County AIDS Program	San Mateo	California	United States	943055107
5	Harbor-UCLA Med. Ctr. CRS	Torrance	California	United States	90502
6	University of Colorado Hospital CRS	Aurora	Colorado	United States	80262
7	Univ. of Miami AIDS CRS	Miami	Florida	United States	331361013
8	Univ. of Hawaii at Manoa, Leahi Hosp.	Honolulu	Hawaii	United States	96816
9	Northwestern University CRS	Chicago	Illinois	United States	60611
10	Weiss Memorial Hosp.	Chicago	Illinois	United States	60640
11	Indiana Univ. School of Medicine, Wishard Memorial	Indianapolis	Indiana	United States	462025250
12	Indiana Univ. School of Medicine, Infectious Disease Research Clinic	Indianapolis	Indiana	United States	46202
13	Univ. of Iowa Healthcare, Div. of Infectious Diseases	Iowa City	Iowa	United States	52242
14	Tulane Hemophilia Treatment Ctr.	New Orleans	Louisiana	United States	70112
15	Johns Hopkins Adult AIDS CRS	Baltimore	Maryland	United States	21287
16	Massachusetts General Hospital ACTG CRS	Boston	Massachusetts	United States	02114
17	Beth Israel Deaconess Med. Ctr., ACTG CRS	Boston	Massachusetts	United States	02215
18	University of Minnesota, ACTU	Minneapolis	Minnesota	United States	55455
19	St. Louis ConnectCare, Infectious Diseases Clinic	Saint Louis	Missouri	United States	63112
20	Washington U CRS	Saint Louis	Missouri	United States
21	Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.	Omaha	Nebraska	United States	681985130
22	Beth Israel Med. Ctr. (Mt. Sinai)	New York	New York	United States	10003
23	NY Univ. HIV/AIDS CRS	New York	New York	United States	10016
24	Beth Israel Med. Ctr., ACTU	New York	New York	United States
25	Univ. of Rochester ACTG CRS	Rochester	New York	United States	14642
26	Unc Aids Crs	Chapel Hill	North Carolina	United States	275997215
27	Carolinas HealthCare System, Carolinas Med. Ctr.	Charlotte	North Carolina	United States	28203
28	Regional Center for Infectious Disease, Wendover Medical Center CRS	Greensboro	North Carolina	United States	27401
29	Univ. of Cincinnati CRS	Cincinnati	Ohio	United States	452670405
30	Case CRS	Cleveland	Ohio	United States	44106
31	MetroHealth CRS	Cleveland	Ohio	United States	441091998
32	The Ohio State Univ. AIDS CRS	Columbus	Ohio	United States	432101228
33	Hosp. of the Univ. of Pennsylvania CRS	Philadelphia	Pennsylvania	United States	19104
34	University of Washington AIDS CRS	Seattle	Washington	United States	98104

Sponsors and Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Study Chair: Havlir D; Richman D,
• Study Chair: Collier A,
• Study Chair: Hirsch M,
• Study Chair: Tebas P,

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT00000916
• Other Study ID Numbers: A5025; 10873; ACTG A5025
• First Posted: Aug 31, 2001
• Last Update Posted: Oct 29, 2021
• Last Verified: Oct 1, 2021

• Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID): Drug Therapy, Combination; HIV Protease Inhibitors; Hydroxyurea; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Viral Load
• Additional relevant MeSH terms: HIV Infections; Lamivudine; Zidovudine; Didanosine; Stavudine; Lamivudine, zidovudine drug combination; Indinavir; Hydroxyurea

Study Results

No Results Posted as of Oct 29, 2021