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A Study to Compare the Effectiveness of Different Anti-HIV Drug Regimens in Keeping Levels of HIV in the Blood as Low as Possible 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 A Study to Compare the Effectiveness of Different Anti-HIV Drug Regimens in Keeping Levels of HIV in the Blood as Low as Possible conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Study to Compare the Effectiveness of Different Anti-HIV Drug Regimens in Keeping Levels of HIV in the Blood as Low as Possible Clinical research trials and A Study to Compare the Effectiveness of Different Anti-HIV Drug Regimens in Keeping Levels of HIV in the Blood as Low as Possible 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 A Study to Compare the Effectiveness of Different Anti-HIV Drug Regimens in Keeping Levels of HIV in the Blood as Low as Possible. A Study to Compare the Effectiveness of Different Anti-HIV Drug Regimens in Keeping Levels of HIV in the Blood as Low as Possible 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 A Study to Compare the Effectiveness of Different Anti-HIV Drug Regimens in Keeping Levels of HIV in the Blood as Low as Possible clinical trial. Subjects typically recieve the finest healthcare available for their A Study to Compare the Effectiveness of Different Anti-HIV Drug Regimens in Keeping Levels of HIV in the Blood as Low as Possible 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 > "A" Clinical Trials Conditions > A Study to Compare the Effectiveness of Different Anti-HIV Drug Regimens in Keeping Levels of HIV in the Blood as Low as Possible  A Study to Compare the Effectiveness of Different Anti-HIV Drug Regimens in Keeping Levels of HIV in the Blood as Low as Possible
A Study to Compare the Effectiveness of Different Anti-HIV Drug Regimens in Keeping Levels of HIV in the Blood as Low as Possible
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: This study will look at different anti-HIV drug regimens to see which works best to keep the level of HIV (viral load) in the blood as low as possible during maintenance therapy. You will be assigned randomly (like tossing a coin) to 1 of 3 groups: Group 1: Didanosine plus stavudine plus hydroxyurea (ddI/d4T/HU). Group 2: Didanosine plus stavudine plus efavirenz (ddI/d4T/EFV). Group 3: This group of patients will remain on their current drug regimens. This study will last approximately 3 years; you will receive study medications for the duration of the study. Anti-HIV drug regimens that include protease inhibitors (PIs) are very good at lowering viral load. However, some patients have a rise in HIV levels while on PI maintenance. It may be possible to keep HIV levels low using another class of drugs for maintenance that are easier to take and less expensive than PIs. If viral load increases while a patient is taking this second group of drugs, it may be possible to restart the PI drug regimen and again decrease HIV levels.
Details: Combination antiretroviral therapies using protease inhibitors (PIs) are capable of suppressing plasma HIV RNA to undetectable levels. However, approximately 10% of patients who achieve undetectable viral loads will experience a detectable rise in HIV RNA each year. When HIV replication has been suppressed to very low levels, it may be possible to consolidate antiretroviral therapy into a simpler and potentially less toxic "maintenance" regimen without a PI. Such a regimen would ideally be potent enough to continue to maintain viral suppression but use agents that are better tolerated, more easily salvaged, less expensive, and/or more convenient than PI-containing regimens. Subsequent rises in HIV viremia with non-PI maintenance regimens may respond to resumption of the pre-maintenance PI-containing regimen, extending the use of the potent PI class. Patients are randomized 1:1:1 to treatment with ddI/d4T/HU (Arm A) versus ddI/d4T/EFV (Arm B) versus continuation of the pre-entry PI-containing regimen (Arm C). Viral load is measured at Weeks 1, 2, 4, 8, 12, 16, 20, and 24, then every 8 weeks for up to 3 years. Upon virologic failure (plasma HIV RNA greater than or equal to 200 copies/ml), or drug intolerance, patients on the maintenance regimens (Arms A and B) restart their pre-entry PI-containing regimen. Patients on Arm C are managed according to best medical judgment of their primary care provider in the event of virologic failure.
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria You may be eligible for this study if you: - Are at least 13 years old (need consent if under 18). - Are HIV-positive. - Are taking your first anti-HIV drug regimen, which must include a PI and at least one NRTI (nucleoside reverse transcriptase inhibitor) and have been on this regimen for at least 12 months. - Have a viral load less than 400 copies/ml for at least 12 months prior to study entry, and have a viral load less than 50 copies/ml within 60 days of study entry. - Have a CD4 cell count of at least 200 cells/mm3 within 60 days of study entry. - Are willing to go back on the drugs you are currently on, if necessary. - Are willing to use effective methods of birth control during the study and for 3 months after. Exclusion Criteria You will not be eligible for this study if you: - Have taken ddI, d4T, or HU for more than 2 weeks. - Have taken any NNRTI (non-nucleoside reverse transcriptase inhibitor) for more than 7 days. - Have ever taken EFV. - Have received an HIV vaccine within 30 days prior to study entry. - Have an AIDS-related cancer that requires chemotherapy. - Have or have had pancreatic disease. - Are being treated for a significant illness. - Abuse drugs or alcohol. - Are pregnant or breast-feeding. - Are allergic to any study drugs. - Have received certain medications.
Total Enrollment: 150
Location and Contact Information:
Overall Study Official:
DavidWohl, Study Chair,
Beth Israel Med Ctr
New York City, New York, 10003
United States
Chelsea Ctr
New York City, New York, 10021
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Willow Clinic
Menlo Park, California, 94025
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699
United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Additional Information:
Study ID Numbers: ACTG A5039;
Study Start Date: July 1998
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000939
Other Hiv Infections Studies:
1. Study of How Indinavir (an Anti-HIV Drug) and Rifabutin (a Drug Used to Treat MAC, an HIV-Associated Disease) Interact in HIV-Positive and HIV-Negative Adults
2. A Pharmacokinetic Study of L-697,661 Alone and in Combination with Zidovudine
3. Safety of an Oral HIV Vaccine in HIV Uninfected Volunteers
4. A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV Envelope Vaccine (HIVAC-1e) in Combination With a Panel of Subunit Recombinant HIV Envelope Vaccines
5. A Randomized Trial to Evaluate the Safety and Efficacy of Combination Therapy With Retrovir ( AZT ) and HIVID ( ddC ) Versus Retrovir, HIVID, and Wellferon ( Interferon alfa-n1 ) for the Treatment of HIV Infection
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A Study to Compare the Effectiveness of Different Anti-HIV Drug Regimens in Keeping Levels of HIV in the Blood as Low as Possible
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