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Effectiveness of the Early Addition of Abacavir to an Anti-HIV Drug Combination Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Effectiveness of the Early Addition of Abacavir to an Anti-HIV Drug Combination conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Effectiveness of the Early Addition of Abacavir to an Anti-HIV Drug Combination Clinical research trials and Effectiveness of the Early Addition of Abacavir to an Anti-HIV Drug Combination healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Effectiveness of the Early Addition of Abacavir to an Anti-HIV Drug Combination. Effectiveness of the Early Addition of Abacavir to an Anti-HIV Drug Combination Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Effectiveness of the Early Addition of Abacavir to an Anti-HIV Drug Combination clinical trial. Human subjects often receive the most effective healthcare possible for their Effectiveness of the Early Addition of Abacavir to an Anti-HIV Drug Combination condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Effectiveness of the Early Addition of Abacavir to an Anti-HIV Drug Combination  Effectiveness of the Early Addition of Abacavir to an Anti-HIV Drug Combination
Effectiveness of the Early Addition of Abacavir to an Anti-HIV Drug Combination
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to see if adding 1 drug to an anti-HIV drug combination early in treatment against HIV can lower the viral load (amount of HIV in the blood) to a level so low that it cannot be measured (undetectable). The drug that will be added to a treatment is abacavir (ABC). Many patients who take 3 anti-HIV drugs together are able to achieve very low viral loads, for example, viral loads below 50 copies/ml. However, some patients taking only 3 drugs are not able to achieve a viral load this low. Doctors hope that, by adding the drug ABC to a current treatment, a viral load below 50 copies/ml can be achieved. Doctors would like to find out if it is effective to start patients on 3 drugs and then add another drug (treatment intensification) if the treatment is not working as well as hoped.
Details: Combination antiretroviral therapy can offer patients potent suppression of HIV replication and improved immunologic functioning. However, despite aggressive antiretroviral regimens currently in use, only about 50 to 60 percent of patients attain plasma viral loads below 50 copies/ml after 24 weeks. Initiating treatment with a 4-drug regimen may increase this percentage, but this may also contribute to patient non-adherence, drug-related toxicities, potential cross-resistance to drugs used in future regimens, and high financial costs. Another strategy is early intensification (adding a single drug to an existing regimen) in patients who are at risk for attaining incomplete viral suppression after 24 weeks of therapy. ABC may produce a significant antiviral effect when used as an intensification agent in patients on a stable antiretroviral regimen. The results of this study will offer insight into the potential benefits of early treatment intensification. Patients entering this study will have initiated potent antiretroviral therapy. Between 60 and 90 days [AS PER AMENDMENT 1/9/01: 60 and 104 days] after beginning their background regimen, patients are randomized to add either ABC (Arm A) or a matching placebo (Arm B) for 12 weeks. Patients completing 12 weeks of treatment continue on study for an additional 24 weeks to Week 36. Patients discontinue treatment if virologic failure occurs at any time. Patients still return to the clinic for HIV-1 RNA measurements at Weeks 12 and 36, depending on when discontinuation occurred. Patients who discontinue treatment at or after Week 12 due to virologic failure are offered open-label ABC for the remainder of the study (through Week 36). Blood samples are collected at Weeks 4, 8, 12, 20, 28, and 36. Plasma samples for population sequencing of HIV-1 PR and RT genes are collected on all patients at study entry and at the time of virologic failure. Baseline genotype (presence or absence of PR and RT resistance mutations and number of resistance mutations) is correlated to treatment outcome. Samples from the time of failure are analyzed for the accumulation of additional resistance mutations. [AS PER AMENDMENT 5/5/00: Patients and their primary care physicians will be unblinded to the patient's treatment after the study is completed at Week 36 or if virologic failure occurs at or after Week 12 [AS PER AMENDMENT 1/9/01: or if ABC hypersensitivity is suspected].]
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are HIV-positive. - Have been taking anti-HIV therapy that includes at least 3 anti-HIV drugs and is an acceptable anti-HIV drug combination for 60 to 104 days before study treatment. Patients must not have changed any of the drugs in the 28 days before study entry. (This study has been changed by extending the number of days that anti-HIV therapy has been received.) - Have a viral load greater than 500 but less than or equal to 10,000 copies/ml and have had a significant decrease in viral load between 49 and 84 days after starting this anti-HIV therapy. (This study has been changed by extending the length of time of viral load decrease.) - Are at least 13 years old (consent of parent or guardian required if under 18). - Agree to practice abstinence or use barrier method of birth control (such as condoms) during the study and for 3 months after. Exclusion Criteria Patients will not be eligible for this study if they: - Have ever taken ABC. - Have received anti-HIV therapy for more than 104 days in the past. (This study has been changed by extending the number of days that anti-HIV therapy has been received.) - Have a fever for 7 days in the 30 days before study entry. - Have cancer, including Kaposi's sarcoma, that requires chemotherapy. - Have an active infection that requires treatment in the 21 days before study entry. - Have any opportunistic (AIDS-related) infection or disease that requires a change in medication in the 14 days before study entry. - Have any medical condition or history of an illness that the doctor feels would place them at risk or make them unable to complete the study. - Are taking drugs that affect the immune system or any experimental anti-HIV drugs, except for their current drug combination. - Are taking St. John's wort. (This study has been changed. Previously, patients taking St. John's wort were eligible.) - Have received a vaccine in the 21 days before study entry. - Are pregnant or breast-feeding.
Total Enrollment: 80
Location and Contact Information:
Overall Study Official:
JohnBartlett, Study Chair,
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699
United States
State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore, Maryland, 212052196
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Philadelphia Veterans Administration Med Ctr
Philadelphia, Pennsylvania, 19104
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, 75390
United States
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
New York City, New York, 10021
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Emory Univ
Atlanta, Georgia, 30308
United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
Univ of Washington
Seattle, Washington, 98104
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Univ of Puerto Rico
San Juan, , 009365067
Puerto Rico
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Willow Clinic
Menlo Park, California, 94025
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Additional Information:
Study ID Numbers: ACTG A5064; AACTG A5064
Study Start Date: November 1999
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001132
Other Hiv Infections Studies:
1. A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients
2. A Phase I Trial of Intranasal Peptide T: Safety, Toxicity, and Pharmacokinetics in Human Immunodeficiency Virus-1 (HIV-1) Infected Patients.
3. A Study of the Safety and Effectiveness of Hydroxyurea in Patients on Potent Antiretroviral Therapy and Who Have Less Than 200 Copies/ml of HIV RNA in Their Blood
4. The Safety and Effectiveness of Interleukin-2 Plus Zidovudine in Patients with AIDS or AIDS Related Complex
5. A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
Other Texas Clinical Trials
Other Dallas Clinical Trials
Effectiveness of the Early Addition of Abacavir to an Anti-HIV Drug Combination
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