Safety and Effectiveness of Combining Hydroxyurea (HU) With Didanosine (ddI) and Stavudine (d4T) for Treatment of HIV-Infected Adults
NCT ID: NCT00002427
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
225 participants
INTERVENTIONAL
1999-05-31
Brief Summary
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HU plus ddI plus d4T appears to be a suitable anti-HIV drug combination for long-term control of HIV. This combination can sharply decrease viral load (level of HIV in the body) with few side effects, making it easy to take.
Detailed Description
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Patients are stratified by antiretroviral experience: naive (no more than 2 weeks of therapy) versus experienced (more than 2 weeks). Patients must discontinue all antiretroviral therapy for at least 28 days prior to randomization to 1 of 9 HU treatment arms. Treatment arms are divided into 3 HU dose categories: very low, low, and medium. Within each category HU is administered daily on 3 different dosing schedules. Depending on viral load, patients on the very low and low dose arms may have the opportunity to intensify their HU dose at any time beyond Week 12, provided no Grade 3 or 4 HU-related toxicity is present (these patients are monitored for an additional 8 weeks following intensification). All patients receive ddI and d4T at the same doses every day. When 50% of patients have completed 24 weeks of treatment, an analysis is made to determine whether or not to continue the 52-week study without modifications. Patients are monitored periodically for changes in plasma HIV RNA, CD4 cell counts, weight, and symptoms.
Conditions
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Study Design
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FACTORIAL
TREATMENT
Interventions
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Hydroxyurea
Stavudine
Didanosine
Eligibility Criteria
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Inclusion Criteria
* Are HIV-positive.
* Have a viral load of 5,000 to 100,000 copies/ml.
* Are willing to stop all anti-HIV medications for at least 28 days before receiving study drugs.
* Are at least 18 years old.
Exclusion Criteria
* Have a history of opportunistic (AIDS-related) infection.
* Have a history of pancreatitis or other serious condition.
* Have any cancer that will require chemotherapy within the next 24 weeks.
* Are allergic to ddI or d4T.
* Have received an HIV vaccine within 28 days of study entry.
* Have received a red blood cell transfusion within the past 60 days, or have had repeated transfusions at any time in the past.
* Abuse alcohol or drugs.
* Have received certain medications.
18 Years
ALL
No
Sponsors
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Research Institute for Genetic and Human Therapy
OTHER
Principal Investigators
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Franco Lori
Role: STUDY_CHAIR
Julianna Lisziewicz
Role: STUDY_CHAIR
Locations
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AIDS Healthcare Foundation
Los Angeles, California, United States
San Francisco VA Med Ctr
San Francisco, California, United States
Gary Blick MD
Stamford, Connecticut, United States
Dr Bruce Rashbaum
Washington D.C., District of Columbia, United States
IDC Research Initiative
Altamonte Springs, Florida, United States
Boulevard Comprehensive Care Ctr
Jacksonville, Florida, United States
Center for Quality Care
Tampa, Florida, United States
AIDS Research Consortium of Atlanta Inc
Atlanta, Georgia, United States
New England Med Ctr
Boston, Massachusetts, United States
Albany Med College
Albany, New York, United States
Mt Vernon Hosp
Mount Vernon, New York, United States
Univ of Pennsylvania Med Ctr
Philadelphia, Pennsylvania, United States
Thomas Jefferson Univ
Philadelphia, Pennsylvania, United States
Coastal Carolina Research Ctr
Mt. Pleasant, South Carolina, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, United States
Univ of Texas Med Branch
Galveston, Texas, United States
Montrose Clinic
Houston, Texas, United States
Swedish Med Ctr
Seattle, Washington, United States
Countries
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Other Identifiers
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RIGHT 702
Identifier Type: -
Identifier Source: secondary_id
304A
Identifier Type: -
Identifier Source: org_study_id