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Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment 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 Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment Clinical research trials and Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment 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 Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment. Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment 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 Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment clinical trial. Human subjects often get the best healthcare possible for their Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment 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 > "S" Clinical Trials Conditions > Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment  Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment
Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment
For Condition: HIV Infections
Status: Completed
Sponsor(s): Gilead Sciences , Glaxo Wellcome,Dupont Pharmaceuticals
Synopsis: The purpose of this study is to see if it is safe and effective to give adefovir dipivoxil plus abacavir (ABC) plus efavirenz (EFV) plus amprenavir (APV) to HIV-infected patients who have failed to respond to previous treatment with protease inhibitors (PIs).
Details: Patients receive a treatment regimen of adefovir dipivoxil, abacavir, efavirenz, and amprenavir for 24 weeks. During the study, patients are evaluated for changes from baseline in plasma HIV-1 RNA levels and lymphocyte subsets and for development of adverse events and toxicities. Patients who experience virologic failure are discontinued from the study. After Week 24, patients with documented virologic response are eligible to continue receiving the study treatment and to attend scheduled follow-up visits.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria You may be eligible for this study if you: - Are HIV-positive. - Had an HIV level of at least 2,000 copies/ml after 6 months of treatment with at least 1 PI other than amprenavir (meaning you failed PI treatment). - Are at least 13 years old (need consent of parent or guardian if under 18). - Are able to complete the study. - Agree to use effective barrier methods of birth control, such as condoms, during the study. Exclusion Criteria You will not be eligible for this study if you: - Have certain serious medical conditions, including AIDS-related cancers (except Kaposi's sarcoma) that require treatment during the study. - Have ever taken or are allergic to adefovir dipivoxil, ABC, APV, EFV. - Are participating in another anti-HIV drug trial during this study. - Have taken certain medications within 30 days prior to study entry, including medications that affect your immune system. - Have been diagnosed with hepatitis within the past 30 days. - Abuse alcohol or drugs. - Are pregnant or breast-feeding. - Have ever taken NNRTIs. - Have ever taken ddI or d4T. - Have received chemotherapy or radiation therapy within 30 days prior to study entry.
Total Enrollment: 25
Location and Contact Information:
Hampton Roads Med Specialists
Hampton, Virginia, 23666
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
Pacific Oaks Med Group
Beverly Hills, California, 90211
United States
Brown Univ School of Medicine
Providence, Rhode Island, 02908
United States
Univ of Colorado / Health Science Ctr
Denver, Colorado, 80262
United States
Additional Information:
Study ID Numbers: 299A; ICC 605
Study Start Date:
Record last reviewed: November 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002419
Other Hiv Infections Studies:
1. Discontinuation of Antiretroviral Therapy in Patients With Asymptomatic HIV Infection
2. Study Of A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy
3. A Study to Test the Safety of Three Experimental HIV Vaccines
4. A Study of 1592U89 in HIV-Infected Adults
5. Garlic in hyperlipidemia caused by HAART
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Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment
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