Effects of treatment intensification with hydroxyurea in HIV-infected patients with virologic suppression.
D V Havlir, P B Gilbert, K Bennett...
https://pubmed.ncbi.nlm.nih.gov/11504959Completed
Phase 2
Age: 13Years +
All Genders
ID00000916
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
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-29
399
Participants Needed
34
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Age: 13Years +
All Genders
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 34 locations
1
Alabama Therapeutics CRS
Birmingham, Alabama, United States, 35294
Status Unknown
2
Stanford CRS
Palo Alto, California, United States, 943055107
Status Unknown
3
Ucsd, Avrc Crs
San Diego, California, United States, 921036325
Status Unknown
4
San Mateo County AIDS Program
San Mateo, California, United States, 943055107
Status Unknown
5
Harbor-UCLA Med. Ctr. CRS
Torrance, California, United States, 90502
Status Unknown
6
University of Colorado Hospital CRS
Aurora, Colorado, United States, 80262
Status Unknown
7
Univ. of Miami AIDS CRS
Miami, Florida, United States, 331361013
Status Unknown
8
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States, 96816
Status Unknown
9
Northwestern University CRS
Chicago, Illinois, United States, 60611
Status Unknown
10
Weiss Memorial Hosp.
Chicago, Illinois, United States, 60640
Status Unknown
11
Indiana Univ. School of Medicine, Wishard Memorial
Indianapolis, Indiana, United States, 462025250
Status Unknown
12
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States, 46202
Status Unknown
13
Univ. of Iowa Healthcare, Div. of Infectious Diseases
Iowa City, Iowa, United States, 52242
Status Unknown
14
Tulane Hemophilia Treatment Ctr.
New Orleans, Louisiana, United States, 70112
Status Unknown
15
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States, 21287
Status Unknown
16
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, United States, 02114
Status Unknown
17
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, United States, 02215
Status Unknown
18
University of Minnesota, ACTU
Minneapolis, Minnesota, United States, 55455
Status Unknown
19
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, United States, 63112
Status Unknown
20
Washington U CRS
St Louis, Missouri, United States
Status Unknown
21
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
Omaha, Nebraska, United States, 681985130
Status Unknown
22
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, United States, 10003
Status Unknown
23
NY Univ. HIV/AIDS CRS
New York, New York, United States, 10016
Status Unknown
24
Beth Israel Med. Ctr., ACTU
New York, New York, United States
Status Unknown
25
Univ. of Rochester ACTG CRS
Rochester, New York, United States, 14642
Status Unknown
26
Unc Aids Crs
Chapel Hill, North Carolina, United States, 275997215
Status Unknown
27
Carolinas HealthCare System, Carolinas Med. Ctr.
Charlotte, North Carolina, United States, 28203
Status Unknown
28
Regional Center for Infectious Disease, Wendover Medical Center CRS
Greensboro, North Carolina, United States, 27401
Status Unknown
29
Univ. of Cincinnati CRS
Cincinnati, Ohio, United States, 452670405
Status Unknown
30
Case CRS
Cleveland, Ohio, United States, 44106
Status Unknown
31
MetroHealth CRS
Cleveland, Ohio, United States, 441091998
Status Unknown
32
The Ohio State Univ. AIDS CRS
Columbus, Ohio, United States, 432101228
Status Unknown
33
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, United States, 19104
Status Unknown
34
University of Washington AIDS CRS
Seattle, Washington, United States, 98104
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
RANDOMIZED
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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