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A Study to Compare Three Doses of T-20 When Given in Combination with Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about A Study to Compare Three Doses of T-20 When Given in Combination with Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Study to Compare Three Doses of T-20 When Given in Combination with Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults Clinical research trials and A Study to Compare Three Doses of T-20 When Given in Combination with Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A Study to Compare Three Doses of T-20 When Given in Combination with Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults. A Study to Compare Three Doses of T-20 When Given in Combination with Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a A Study to Compare Three Doses of T-20 When Given in Combination with Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults clinical trial. Human subjects often get the best healthcare possible for their A Study to Compare Three Doses of T-20 When Given in Combination with Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study to Compare Three Doses of T-20 When Given in Combination with Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults  A Study to Compare Three Doses of T-20 When Given in Combination with Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults
A Study to Compare Three Doses of T-20 When Given in Combination with Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Trimeris ,
Synopsis: The purpose of this study is to see if it is safe and effective to give T-20, a new type of anti-HIV drug, with a combination of other anti-HIV drugs. The other anti-HIV drugs used are abacavir (ABC), amprenavir (APV), ritonavir (RTV), and efavirenz (EFV). Three different doses of T-20 are tested.
Details: Patients are assigned to one of four groups. Three dose groups receive a background antiretroviral regimen (ABC, APV, RTV, and EFV) and T-20, which is given at one of three doses on a twice-daily regimen. The fourth group (control) receives the background antiretroviral regimen alone. For each treatment group, 17 patients are enrolled. Treatment is administered for 16 weeks, followed by a 32-week treatment extension, and a 2-week follow-up period. The following are assessed throughout the trial: safety parameters (as measured by hematology, clinical chemistry, urinalysis, and treatment-emergent adverse events); virologic and immunologic activity; phenotypic and genotypic resistance; T-20 plasma levels; and pharmacokinetics of T-20 and oral antiretrovirals. The total study duration is 1 year.
Eligibility:
Study Type: Interventional, Treatment, Pharmacokinetics 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 an HIV level (viral load) between 400 and 100,000 copies/ml at the screening visit. - Have taken at least 1 PI (protease inhibitor) for at least 16 weeks, and have had no interruptions in their most recent PI-containing anti-HIV drug regimen. - Are at least 18 years old. - Agree to abstinence or use of 2 effective methods of birth control, including a barrier method, during the study. Exclusion Criteria Patients will not be eligible for this study if they: - Have ever taken an NNRTI (nonnucleoside reverse transcriptase inhibitor). - Have an opportunistic (HIV-related) infection. - Have had an unexplained fever of at least 38.5 C for 7 days in a row within 30 days prior to screening. - Have had diarrhea lasting at least 15 days within 30 days prior to screening. - Have ever taken abacavir, amprenavir, or efavirenz (ABC, APV, or EFV). - Have certain genetic characteristics (drug resistance mutations) that could change the way a drug acts in the body. - Are allergic to any of the study medications. - Have a tumor other than certain skin or cervical cancers. - Are on chemotherapy that cannot be discontinued during the study. - Are taking an investigational drug within 30 days prior to screening. - Have ever received an HIV vaccine. - Are taking certain medications. - Abuse drugs or alcohol. - Have hemophilia or another blood clotting disorder. - Have had an organ transplant. - Are pregnant or breast-feeding.
Total Enrollment: 68
Location and Contact Information:
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
Associates of Med and Mental Health
Tulsa, Oklahoma, 74114
United States
Trimeris Inc
Durham, North Carolina, 27707
United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15261
United States
Central Texas Clinical Research
Austin, Texas, 78705
United States
Quest Clinical Research
San Francisco, California, 94115
United States
IDC Research Initiative
Altamonte Springs, Florida, 32701
United States
New York Univ Med Ctr
New York City, New York, 10016
United States
UCSD
San Diego, California, 92103
United States
UCLA Care Ctr
Los Angeles, California, 90095
United States
Donald Northfelt
Palm Springs, California, 92270
United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
United States
ViRx Inc
Palm Springs, California, 92262
United States
Gary Richmond MD
Ft. Lauderdale, Florida, 33316
United States
Pacific Oaks Research
Beverly Hills, California, 90211
United States
ViRx Inc
San Francisco, California, 94109
United States
Washington Univ School of Medicine
St. Louis, Missouri, 63110
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 200091104
United States
Pennsylvania Oncology and Hematology Associates
Philadelphia, Pennsylvania, 19106
United States
Additional Information:
Study ID Numbers: 295B; T-20-206
Study Start Date: May 1999
Record last reviewed: June 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002239
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3. Safety and Efficacy of Amphotericin B Lipid Complex in the Treatment of Cryptococcal Meningitis in Patients With the Acquired Immunodeficiency Syndrome
4. A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 mg) or Rifabutin (300 mg) or Placebo
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A Study to Compare Three Doses of T-20 When Given in Combination with Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults
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