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Safety and Effectiveness of Combining Hydroxyurea (HU) with Didanosine (ddI) and Stavudine (d4T) for Treatment of HIV-Infected Adults Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Safety and Effectiveness of Combining Hydroxyurea (HU) with Didanosine (ddI) and Stavudine (d4T) for Treatment of HIV-Infected Adults conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Safety and Effectiveness of Combining Hydroxyurea (HU) with Didanosine (ddI) and Stavudine (d4T) for Treatment of HIV-Infected Adults Clinical research trials and Safety and Effectiveness of Combining Hydroxyurea (HU) with Didanosine (ddI) and Stavudine (d4T) for Treatment of HIV-Infected Adults healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Safety and Effectiveness of Combining Hydroxyurea (HU) with Didanosine (ddI) and Stavudine (d4T) for Treatment of HIV-Infected Adults. Safety and Effectiveness of Combining Hydroxyurea (HU) with Didanosine (ddI) and Stavudine (d4T) for Treatment of HIV-Infected Adults Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Safety and Effectiveness of Combining Hydroxyurea (HU) with Didanosine (ddI) and Stavudine (d4T) for Treatment of HIV-Infected Adults clinical trial. Participants typically obtain the most effective healthcare available for their Safety and Effectiveness of Combining Hydroxyurea (HU) with Didanosine (ddI) and Stavudine (d4T) for Treatment of HIV-Infected Adults condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Safety and Effectiveness of Combining Hydroxyurea (HU) with Didanosine (ddI) and Stavudine (d4T) for Treatment of HIV-Infected Adults  Safety and Effectiveness of Combining Hydroxyurea (HU) with Didanosine (ddI) and Stavudine (d4T) for Treatment of HIV-Infected Adults
Safety and Effectiveness of Combining Hydroxyurea (HU) with Didanosine (ddI) and Stavudine (d4T) for Treatment of HIV-Infected Adults
For Condition: HIV Infections
Status: Completed
Sponsor(s): Research Institute for Genetic and Human Therapy ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Factorial Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 225
Location and Contact Information:
Overall Study Official:
FrancoLori, Study Chair,
Thomas Jefferson Univ
Philadelphia, Pennsylvania, 19107
United States
San Francisco VA Med Ctr
San Francisco, California, 94121
United States
AIDS Research Consortium of Atlanta Inc
Atlanta, Georgia, 30308
United States
Coastal Carolina Research Ctr
Mount Pleasant, South Carolina, 29464
United States
Univ of Texas Med Branch
Galveston, Texas, 775550835
United States
Boulevard Comprehensive Care Ctr
Jacksonville, Florida, 32209
United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
United States
New England Med Ctr
Boston, Massachusetts, 02111
United States
Mt Vernon Hosp
Mt. Vernon, New York, 10550
United States
IDC Research Initiative
Altamonte Springs, Florida, 32701
United States
Center for Quality Care
Tampa, Florida, 33609
United States
Albany Med College
Albany, New York, 122083479
United States
Montrose Clinic
Houston, Texas, 77006
United States
Gary Blick MD
Stamford, Connecticut, 06901
United States
Swedish Med Ctr
Seattle, Washington, 98122
United States
Dr Bruce Rashbaum
Washington D.C., District of Columbia, 20037
United States
AIDS Healthcare Foundation
Los Angeles, California, 90027
United States
Univ of Pennsylvania Med Ctr
Philadelphia, Pennsylvania, 19104
United States
Additional Information:
Study ID Numbers: 304A; RIGHT 702
Study Start Date: May 1999
Record last reviewed: August 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002427
Other Hiv Infections Studies:
1. The Safety and Effectiveness of Zidovudine in the Treatment of Patients with Early AIDS Related Complex
2. A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-avium Complex (MAC) Bacteremia in Patients With AIDS
3. A Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV Treatment
4. A Pilot Study of the Combination of Retinoic Acid and Interferon-Alpha2a for the Treatment of Lymphoproliferative Disorders in Children with Immunodeficiency Syndromes
5. A Study to Compare the Effectiveness of Two Anti-HIV Drug Combinations
Related Studies:
Other HIV Infections Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Safety and Effectiveness of Combining Hydroxyurea (HU) with Didanosine (ddI) and Stavudine (d4T) for Treatment of HIV-Infected Adults
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