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Safety and Effectiveness of Giving Adefovir (Preveon) Plus Other Anti-HIV Drugs to HIV-Infected Patients Who Have Not Responded to Other Anti-HIV Drug Combinations 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 Safety and Effectiveness of Giving Adefovir (Preveon) Plus Other Anti-HIV Drugs to HIV-Infected Patients Who Have Not Responded to Other Anti-HIV Drug Combinations conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Safety and Effectiveness of Giving Adefovir (Preveon) Plus Other Anti-HIV Drugs to HIV-Infected Patients Who Have Not Responded to Other Anti-HIV Drug Combinations Clinical research trials and Safety and Effectiveness of Giving Adefovir (Preveon) Plus Other Anti-HIV Drugs to HIV-Infected Patients Who Have Not Responded to Other Anti-HIV Drug Combinations 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 Safety and Effectiveness of Giving Adefovir (Preveon) Plus Other Anti-HIV Drugs to HIV-Infected Patients Who Have Not Responded to Other Anti-HIV Drug Combinations. Safety and Effectiveness of Giving Adefovir (Preveon) Plus Other Anti-HIV Drugs to HIV-Infected Patients Who Have Not Responded to Other Anti-HIV Drug Combinations 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 Safety and Effectiveness of Giving Adefovir (Preveon) Plus Other Anti-HIV Drugs to HIV-Infected Patients Who Have Not Responded to Other Anti-HIV Drug Combinations clinical trial. Participants frequently get the best healthcare available for their Safety and Effectiveness of Giving Adefovir (Preveon) Plus Other Anti-HIV Drugs to HIV-Infected Patients Who Have Not Responded to Other Anti-HIV Drug Combinations 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 > "S" Clinical Trials Conditions > Safety and Effectiveness of Giving Adefovir (Preveon) Plus Other Anti-HIV Drugs to HIV-Infected Patients Who Have Not Responded to Other Anti-HIV Drug Combinations  Safety and Effectiveness of Giving Adefovir (Preveon) Plus Other Anti-HIV Drugs to HIV-Infected Patients Who Have Not Responded to Other Anti-HIV Drug Combinations
Safety and Effectiveness of Giving Adefovir (Preveon) Plus Other Anti-HIV Drugs to HIV-Infected Patients Who Have Not Responded to Other Anti-HIV Drug Combinations
For Condition: HIV Infections
Status: Completed
Sponsor(s): Gilead Sciences ,
Synopsis: The purpose of this study is to see if it is safe and effective to give adefovir plus other anti-HIV drugs to HIV-infected patients who have failed other anti-HIV drug combinations. This study will try to make adefovir available to all AIDS patients who need it. Some patients do not respond to anti-HIV drug combinations, even when different combinations are tried. Adefovir may be able to help these patients fight HIV.
Details: Recent studies indicate that the use of triple-combination therapy, in particular the combinations of reverse transcriptase inhibitors and a protease inhibitor, can result in a significant decrease in plasma HIV-1 RNA levels and an increase in CD4 cell count. Continued follow-up of patients taking triple-combination drug regimens has in some cases demonstrated sustained suppression of plasma HIV-1 RNA levels for up to 18 months. Furthermore, despite the potent antiviral effect of some triple combinations, a percentage of patients continue to have measurable levels (more than 500 copies/ml) of HIV-1 RNA in plasma, even when treated with a combination of 2 reverse transcriptase inhibitors and indinavir. Over time, some patients experience a rebound of plasma HIV-1 RNA for reasons that are not well understood. [AS PER AMENDMENT 7/8/98: Randomization to 2 dose levels may allow more patients to derive therapeutic benefit from Preveon by minimizing adverse effects.] Patients not previously enrolled in clinical trials of Preveon are randomized to 1 of 2 doses of Preveon orally once daily and L-carnitine orally once daily. [AS PER AMENDMENT 7/8/98: Patients must receive other antiretroviral agents concomitantly with Preveon; at least 1 other antiretroviral agent must be added with Preveon that was not previously administered to the patient.Patients previously enrolled in Preveon clinical trials who "roll in" to expanded access and who have received at least 16 weeks of Preveon receive open-label Preveon orally once daily and L-carnitine orally once daily, taken with or without food at the same time each day.] All patients enrolled in expanded access are randomized in a 1:1 fashion to 1 of 2 doses taken orally once daily. Patients initially assigned to the higher dose will have their Preveon dose reduced to the lower dose at Week 16 of treatment. Patients initially assigned to the lower dose continue this dose unless dose modification to an even lower dose for toxicity is required. [AS PER AMENDMENT 7/8/98: Additional informed consent is needed for this reduction due to limited efficacy of the lower dosage in treating HIV infection.]
Eligibility:
Study Type: Interventional, Treatment, Open Label, 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. - Have a CD4 cell count of 50 cells/mm3 or less within the past 2 months. - Have a viral load (level of HIV in the body) of 30,000 copies/ml or more within the past 2 months. - Are at least 13 years old (need consent of parent or guardian if under 18). - Have failed to respond to an anti-HIV drug combination that included at least 2 nucleoside reverse transcriptase inhibitors and at least 1 protease inhibitor (PI). - Do not have any other anti-HIV treatment options left. - Agree to use effective methods of birth control during the study. Exclusion Criteria You will not be eligible for this study if you: - Have certain serious medical conditions that would prevent you from completing the study, including serious kidney disorders. - Have taken certain medications, including certain treatments for opportunistic (HIV-related) diseases. - Are pregnant or breast-feeding.
Total Enrollment:
Location and Contact Information:
Gilead Sciences Inc
Foster City, California, 94404
United States
Additional Information:
Study ID Numbers: 232G; GS-97-423
Study Start Date:
Record last reviewed: December 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002398
Other Hiv Infections Studies:
1. Safety and Tolerability of Pegylated Interferon (PEG-IFN) Alfa-2a in HIV Infected People
2. The Biology of HIV Transmission
3. Immunomodulation of HIV-1 Infected Individuals With PEG-Interleukin-2
4. HIV Infection in Homosexual and Bisexual Men
5. Rapid HIV Tests for Women Late in Pregnancy and During Labor
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other Foster City Clinical Trials
Safety and Effectiveness of Giving Adefovir (Preveon) Plus Other Anti-HIV Drugs to HIV-Infected Patients Who Have Not Responded to Other Anti-HIV Drug Combinations
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