Safety and Effectiveness of Combining Hydroxyurea (HU) With Didanosine (ddI) and Stavudine (d4T) for Treatment of HIV-Infected Adults
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Hydroxyurea (Drug); Stavudine (Drug); Didanosine (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Research Institute for Genetic and Human Therapy Official(s) and/or principal investigator(s):
Franco Lori, Study Chair
Julianna Lisziewicz, Study Chair
Summary
The purpose of this study is to compare the safety and effectiveness of 9 doses of HU in
order to find the best dose of HU to use with ddI and d4T in fighting HIV infection.
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.
Clinical Details
Official title: A Phase I/II Study of the Safety and Antiretroviral Activity of Nine Hydroxyurea Regimens in Combination With ddI and d4T in Subjects With HIV Infection
Study design: Treatment, Factorial Assignment, Safety Study
Detailed description:
The combination of HU plus ddI plus d4T appears to be suitable for long-term control of HIV
in that it: (1) has a novel resistance/rebound profile demonstrating virus suppression even
in the presence of ddI-resistant mutants; (2) can produce a pronounced fall in viral load;
and (3) is well tolerated (over 200 patients have been treated for up to 3 years with minimal
side effects).
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
Patients may be eligible for this study if they:
- 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
Patients will not be eligible for this study if they:
- 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.
Locations and Contacts
AIDS Healthcare Foundation, Los Angeles, California 90027, United States
San Francisco VA Med Ctr, San Francisco, California 94121, United States
Gary Blick MD, Stamford, Connecticut 06901, United States
Dr Bruce Rashbaum, Washington, District of Columbia 20037, United States
IDC Research Initiative, Altamonte Springs, Florida 32701, United States
Boulevard Comprehensive Care Ctr, Jacksonville, Florida 32209, United States
Center for Quality Care, Tampa, Florida 33609, United States
AIDS Research Consortium of Atlanta Inc, Atlanta, Georgia 30308, United States
New England Med Ctr, Boston, Massachusetts 02111, United States
Albany Med College, Albany, New York 122083479, United States
Mt Vernon Hosp, Mt. Vernon, New York 10550, United States
Univ of Pennsylvania Med Ctr, Philadelphia, Pennsylvania 19104, United States
Thomas Jefferson Univ, Philadelphia, Pennsylvania 19107, United States
Coastal Carolina Research Ctr, Mount Pleasant, South Carolina 29464, United States
Univ of Texas Southwestern Med Ctr of Dallas, Dallas, Texas 75235, United States
Univ of Texas Med Branch, Galveston, Texas 775550835, United States
Montrose Clinic, Houston, Texas 77006, United States
Swedish Med Ctr, Seattle, Washington 98122, United States
Additional Information
Starting date: May 1999
Last updated: June 23, 2005
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