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Four-Drug Combination Therapy with Zidovudine, Lamivudine, 1592U89 (Abacavir), and 141W94 (Amprenavir) in HIV-Infected Patients Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Four-Drug Combination Therapy with Zidovudine, Lamivudine, 1592U89 (Abacavir), and 141W94 (Amprenavir) in HIV-Infected Patients conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Four-Drug Combination Therapy with Zidovudine, Lamivudine, 1592U89 (Abacavir), and 141W94 (Amprenavir) in HIV-Infected Patients Clinical research trials and Four-Drug Combination Therapy with Zidovudine, Lamivudine, 1592U89 (Abacavir), and 141W94 (Amprenavir) in HIV-Infected Patients medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Four-Drug Combination Therapy with Zidovudine, Lamivudine, 1592U89 (Abacavir), and 141W94 (Amprenavir) in HIV-Infected Patients. Four-Drug Combination Therapy with Zidovudine, Lamivudine, 1592U89 (Abacavir), and 141W94 (Amprenavir) in HIV-Infected Patients Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Four-Drug Combination Therapy with Zidovudine, Lamivudine, 1592U89 (Abacavir), and 141W94 (Amprenavir) in HIV-Infected Patients clinical trial. Subjects typically recieve the finest healthcare available for their Four-Drug Combination Therapy with Zidovudine, Lamivudine, 1592U89 (Abacavir), and 141W94 (Amprenavir) in HIV-Infected Patients condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "F" Clinical Trials Conditions > Four-Drug Combination Therapy with Zidovudine, Lamivudine, 1592U89 (Abacavir), and 141W94 (Amprenavir) in HIV-Infected Patients  Four-Drug Combination Therapy with Zidovudine, Lamivudine, 1592U89 (Abacavir), and 141W94 (Amprenavir) in HIV-Infected Patients
Four-Drug Combination Therapy with Zidovudine, Lamivudine, 1592U89 (Abacavir), and 141W94 (Amprenavir) in HIV-Infected Patients
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Glaxo Wellcome
Synopsis: The purpose of this study is to see if the multidrug combination of zidovudine (ZDV), lamivudine (3TC), 1592U89 (abacavir [ABC]), and 141W94 (amprenavir [APV]) is a safe and effective treatment for HIV-infected patients and if there is a reduction of active HIV in blood and other tissues. HIV infection is a life-changing illness and new HIV treatments must be tested. This study will test if a 4-drug combination will reduce HIV virus activity in blood and other tissues and if it is safe and well tolerated. Doctors also want to know if the multidrug combination is able to decrease viral activity over a long time period.
Details: With effective combination ART, there is a decrease in HIV-1 RNA in plasma after 2 to 3 weeks. A second, slower phase of viral decay is thought to occur in long-lived macrophages, with a minimal contribution from lymphocytes. This study addresses whether there is a third reservoir such as the central nervous system. Additionally, the study aims to provide a better understanding of the type and length of ART required to suppress HIV-1 replication in multiple reservoirs. Patients receive treatment with ZDV, 3TC, ABC, and APV daily for 24 weeks. Clinic visits occur weekly until Week 4, then every 2 weeks until Week 12, then monthly. Blood and urine samples are collected and patients are monitored for clinical or laboratory abnormalities. Laboratory tests to assess side effects and virologic and immunologic parameters, including viral quantification of CSF on all chronically infected patients and selected consenting acutely infected patients, are determined. In a pharmacoeconomic component of this study, patients have interviews and complete questionnaires at 5 clinic visits.
Eligibility:
Study Type: Interventional, Treatment, Open Label, 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 at least 18 years old. - Have a chronic (long-term) HIV infection (greater than 90 days) or a recent HIV infection. - Have a plasma viral load (level of HIV in the blood) of at least 5,000 copies/ml (for chronically infected patients only). - Are able to follow study requirements. - Agree to practice reliable forms of birth control such as barrier or surgical methods, starting 1 month prior to entry and while enrolled in the study. Exclusion Criteria Patients will not be eligible for this study if they: - Have had prior anti-HIV treatment (for recently infected patients only). - Have a history of blood-clotting problems. - Have ever received treatment with protease inhibitors or 3TC. - Are at high risk for developing an infection in the heart. - Are critically ill. - Are mentally disabled, a prisoner, or confined in an institution. - Are breast-feeding or pregnant. - Have gastrointestinal problems that might interfere with drug absorption or are unable to take medicines by mouth. - Need regular blood transfusions. - Have had an unexplained fever higher than 38.5 C for more than 14 days within 30 days of enrollment. - Have an opportunistic (AIDS-related) infection that requires treatment (treatment must be completed 30 days before the start of the study). - Are taking certain medications that may interfere with the study.
Total Enrollment: 25
Location and Contact Information:
Overall Study Official:
MartinMarkowitz, Principal Investigator,
Aaron Diamond AIDS Res Ctr *Recruiting*
New York City, New York, 10016
United States
Recruiting Martin Markowitz 212-448-5020
Additional Information:
Study ID Numbers: AIEDRP AI-04-008; PROA2003
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006617
Other Hiv Infections Studies:
1. RESIST 1: Randomized Evaluation of Strategic Intervention in Multi-Drug Resistant Patients with Tipranavir
2. Curb, Alter, Lower, or Manage Stress in HIV: CALMS-HIV
3. A Study of Megestrol Acetate in HIV-Infected Children
4. A Study of Dextran Sulfate in HIV-Infected Patients and in Patients with AIDS or AIDS Related Complex (ARC)
5. Suppression of Cytomegalovirus Retinitis Utilizing High Dose Intravenous Acyclovir and Oral Zidovudine in Patients With AIDS
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Four-Drug Combination Therapy with Zidovudine, Lamivudine, 1592U89 (Abacavir), and 141W94 (Amprenavir) in HIV-Infected Patients
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