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Continued Antiretroviral Therapy with Abacavir, Amprenavir and Efavirenz Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Continued Antiretroviral Therapy with Abacavir, Amprenavir and Efavirenz conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Continued Antiretroviral Therapy with Abacavir, Amprenavir and Efavirenz Clinical research trials and Continued Antiretroviral Therapy with Abacavir, Amprenavir and Efavirenz medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Continued Antiretroviral Therapy with Abacavir, Amprenavir and Efavirenz. Continued Antiretroviral Therapy with Abacavir, Amprenavir and Efavirenz Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Continued Antiretroviral Therapy with Abacavir, Amprenavir and Efavirenz clinical trial. Participants frequently get the best healthcare available for their Continued Antiretroviral Therapy with Abacavir, Amprenavir and Efavirenz condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Continued Antiretroviral Therapy with Abacavir, Amprenavir and Efavirenz  Continued Antiretroviral Therapy with Abacavir, Amprenavir and Efavirenz
Continued Antiretroviral Therapy with Abacavir, Amprenavir and Efavirenz
For Condition: HIV Infection
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: This study will continue to treat and collect safety and efficacy data on patients who participated in Glaxo-Wellcome's multi-center study on combination therapy with abacavir, amprenavir and efavirenz (A Phase II Study Evaluating the Safety and Antiviral Activity of Combination Therapy with 1592U89, 141W94 and DMP 266 (Sustiva) in HIV-1 Infected Subjects with Detectable [greater than 400 Copies/mL] HIV-1 Plasma RNA Despite Treatment with a Protease Inhibitor-Containing Regimen). HIV-infected patients 18 years of age and older who participated in the above study at the NIH site may be eligible for the current study. Participants will be followed every 3 months with a general health evaluation and laboratory tests. This is a NIH study, and information will not be provided to Glaxo Wellcome
Details: In this open-label, single-arm study, HIV-1 infected patients who had, at study entry, a viral burden of at least 500 copies/mL despite 20 weeks of treatment with a protease inhibitor receive combination therapy with three antiretroviral agents that were investigational at the start of study but have since been approved: abacavir, amprenavir, and efavirenz. At the end of 16 weeks, the addition of other antiretroviral agents to the study regimen was permitted. This was originally a multi-center study, but it has been closed at all other sites. It remains open at the NIH to continue to provide therapy to subjects who have received benefit as determined by a decline in viral load from baseline. Safety and viral load data continue to be collected.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION/EXCLUSION CRITERIA: Subjects who were previously enrolled in this protocol when it was a multi-center study and who signed the new informed consent were enrolled. There has been and will be no other new enrollment. Thus, subjects who were not previously enrolled are excluded. Subjects are adults infected with HIV-1 who had, prior to study enrollment, a plasma viral load of at least 500 copies/mL despite at least 20 weeks of treatment with a protease inhibitor and without change in protease inhibitor therapy in the 12 weeks prior to enrollment.
Total Enrollment: 25
Location and Contact Information:
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 980031; 98-I-0031
Study Start Date: November 12, 1997
Record last reviewed: August 16, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001758
Other Hiv Infection Studies:
1. Combination Drug Treatment of Pediatric HIV Infection
2. A Study of Health-Related Quality of Life in HIV-Infected Patients Undergoing Structured Treatment Interruptions of Highly Active Antiretroviral Therapy
3. Differences in Blood Levels of Nevirapine in HIV-infected Patients in Uganda and the United States
4. Immune Responses to HIV in Blood Cells in HIV-Infected and HIV-Uninfected Volunteers
5. Analysis of HIV Genetic Variation in Patients Before Beginning Highly Active Antiretroviral Therapy
Related Studies:
Other HIV Infection Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Continued Antiretroviral Therapy with Abacavir, Amprenavir and Efavirenz
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