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Home > "A" Clinical Trials Conditions > A Study on Amprenavir in Combination with Other Anti-HIV Drugs in HIV-Positive Patients  A Study on Amprenavir in Combination with Other Anti-HIV Drugs in HIV-Positive Patients
A Study on Amprenavir in Combination with Other Anti-HIV Drugs in HIV-Positive Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to compare 4 different combinations of anti-HIV drugs and to determine the number of people whose HIV blood levels decrease to 200 copies/ml or less while on the treatment. This study evaluates the safety of these drug combinations, which include an experimental protease inhibitor (PI), amprenavir. Despite the success that many patients have had with PI treatment regimens, there is still a possibility that patients receiving PIs may continue to have high HIV blood levels. Because of this possibility, alternative drug combinations containing PIs are being studied. It appears that amprenavir, when taken with 3 or 4 other anti-HIV drugs, may be effective in patients with prior PI treatment experience.
Details: A number of studies both within and outside the ACTG have been initiated or are in development to try to address the issue of alternative treatments for patients who either do not achieve or lose virologic control while receiving protease inhibitors (PIs). Amprenavir (APV) is an attractive candidate to investigate as part of salvage regimens because: 1) it has substantial antiretroviral activity; 2) there are preliminary in vitro and in vivo data that suggest that resistance to this agent may be mediated in part by a unique mutation (I50V); and 3) its cross-resistance profile to the approved PIs is uncertain. Patients are selectively randomized to 1 of 4 study arms based on prior PI experience. Those randomized to Arms A, B, or C receive 2 PIs, 1 of which is amprenavir (APV), and those randomized to Arm D receive a single PI (APV) as part of their treatment regimen, as follows: Arm A: APV plus saquinavir soft gel capsule (SQVsgc) plus abacavir (ABC) plus efavirenz (EFV) plus adefovir (ADV). Arm B: APV plus indinavir (IDV) plus ABC plus EFV plus ADV. Arm C: APV plus nelfinavir (NFV) plus ABC plus EFV plus ADV. Arm D: APV plus placebo (NFV, IDV, or SQVsgc) plus ABC plus EFV plus ADV. All patients receive L-carnitine supplementation. All patients receive clinical physical assessments and laboratory testing during study as follows: Weeks 2, 4, and every 4 weeks thereafter. A primary analysis is performed after the last patient has reached 24 weeks. [AS PER AMENDMENT 3/2/00: At that time, all patients are unblinded to their original treatment assignment.] Patients who experience virologic failure are unblinded and may choose 1 of the following 3 options: Continue study medications open-label, permanently discontinue study medications, or selectively continue study medications [AS PER AMENDMENT 3/2/00: from the arm the patient was originally randomized to] and combine with other approved antiretroviral agents. [AS PER AMENDMENT 3/2/00: For patients adding didanosine (ddI) to their regimens, monitoring for the development of pancreatitis is crucial.] Final evaluations are required for those patients who are off drug during the immediate 8-week period following the last dose of study treatment. Beyond 8 weeks, they are followed for incidence of death, cancer, congenital anomalies, and permanent disabilities. [AS PER AMENDMENT 3/2/00: Gilead Sciences has terminated its U.S. development of ADV for HIV infection. Gilead will continue to supply ADV for patients in ACTG 398 until the study closes. Patients who are receiving ADV at the completion of the study may continue to access ADV through the Expanded Access Program, provided that the physician and patient have determined that continued use of ADV is beneficial.]
Eligibility:
Study Type: Interventional, Treatment, Placebo Control, 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 current virologic failure (2 consecutive HIV blood levels above 1,000 copies/ml) while on PIs. - Are over 13 years of age (consent of parent or guardian required if under 18). - Agree to practice abstinence or use effective methods of birth control during the study and for 90 days after. Exclusion Criteria Patients will not be eligible for this study if they: - Have hepatitis within 90 days prior to study entry. - Have a history of a peripheral neuropathy within 60 days of study entry. - Have an unexplained temperature for a 7-day period. - Have chronic diarrhea within 30 days prior to study entry. - Have cancer requiring chemotherapy. - Received any therapy for infection or other illness within 30 days prior to study entry. - Have received certain other medications. - Are pregnant or breast-feeding.
Total Enrollment: 475
Location and Contact Information:
Overall Study Official:
ScottHammer, Study Chair,
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Willow Clinic
Menlo Park, California, 94025
United States
Moses H Cone Memorial Hosp
Greensboro, North Carolina, 27401
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
USC Univ Hosp & Ambulatory Hlth Care Ctr / USC Med Ctr
Los Angeles, California, 900334508
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Howard Univ
Washington D.C., District of Columbia, 20059
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
Emory Univ
Atlanta, Georgia, 30308
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Univ of Washington
Seattle, Washington, 981224304
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850
United States
Univ of Puerto Rico
San Juan, , 009365067
Puerto Rico
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Chelsea Ctr
New York City, New York, 10021
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
Atlanta, Georgia, 303652225
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Univ of Pittsburgh Med Ctr
Pittsburgh, Pennsylvania, 15213
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Queens Med Ctr
Honolulu, Hawaii, 96816
United States
Tripler Army Med Ctr
Tripler AMC, Hawaii, 96859
United States
Additional Information:
Study ID Numbers: ACTG 398; Substudy ACTG 5003s
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000912
Other Hiv Infections Studies:
1. The Safety and Effectiveness of Zidovudine Plus Adefovir in HIV-Infected Patients
2. A Phase II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group
3. Perceived Changes in Body Build and Image in Patients Who Are Now Taking or Recently Have Stopped Taking Anti-HIV Drugs
4. Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma
5. A Study of Foscarnet Plus Ganciclovir in the Treatment of Cytomegalovirus of the Eye in Patients with AIDS Who Have Already Been Treated with Ganciclovir
Related Studies:
Other HIV Infections Clinical Trials
Other Pennsylvania Clinical Trials
Other Hershey Clinical Trials
A Study on Amprenavir in Combination with Other Anti-HIV Drugs in HIV-Positive Patients
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