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Safety and antiviral study of ACH-126, 443 (beta-L-Fd4C) in the treatment of adults with HIV infection and modestly detectable viral load. Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Safety and antiviral study of ACH-126, 443 (beta-L-Fd4C) in the treatment of adults with HIV infection and modestly detectable viral load. conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Safety and antiviral study of ACH-126, 443 (beta-L-Fd4C) in the treatment of adults with HIV infection and modestly detectable viral load. Clinical research trials and Safety and antiviral study of ACH-126, 443 (beta-L-Fd4C) in the treatment of adults with HIV infection and modestly detectable viral load. healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Safety and antiviral study of ACH-126, 443 (beta-L-Fd4C) in the treatment of adults with HIV infection and modestly detectable viral load.. Safety and antiviral study of ACH-126, 443 (beta-L-Fd4C) in the treatment of adults with HIV infection and modestly detectable viral load. Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Safety and antiviral study of ACH-126, 443 (beta-L-Fd4C) in the treatment of adults with HIV infection and modestly detectable viral load. clinical trial. Human subjects often receive the most effective healthcare possible for their Safety and antiviral study of ACH-126, 443 (beta-L-Fd4C) in the treatment of adults with HIV infection and modestly detectable viral load. condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and antiviral study of ACH-126, 443 (beta-L-Fd4C) in the treatment of adults with HIV infection and modestly detectable viral load.  Safety and antiviral study of ACH-126, 443 (beta-L-Fd4C) in the treatment of adults with HIV infection and modestly detectable viral load.
Safety and antiviral study of ACH-126, 443 (beta-L-Fd4C) in the treatment of adults with HIV infection and modestly detectable viral load.
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Achillion Pharmaceuticals ,
Synopsis: To determine safety and efficacy of ACH-126,443 on the treatment of adults with HIV infection who have modestly detectable viral load while on stable triple combination antiretroviral therapy including 3TC.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Adults 18 years of age - Receiving a stable triple combination antiretroviral regimen including 3TC, one other NRTI and either an NNRTI or a protease inhibitor for at least 4 months (16 weeks) - Demonstration of initial viral suppression and subsequent rebound to be defined as an initial virological drop of at least 0.5 Logs on a 3TC-containing regimen - Plasma HIV RNA level > 1000 and < 30,000 copies/mL on two occasions - Genotypically documented M184V variant of HIV RT - Clinically stable HIV status with no AIDS-defining events - CD4 > 200 cells/mm3 - Basic hematologic and chemistry parameters within acceptable limits (defined in protocol) - All women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity of 25 IU/L of b-HCG) within 72 hours prior to the start of study medication - No active opportunistic infection requiring treatment - Subject must be able to provide written informed consent - Baseline laboratory values measured within 28 days of initiating study drug as follows: - HGB9.0g/dl or HCT27% (in the absence of blood transfusions or erythropoietin treatment in the preceding two weeks - Absolute neutrophil count1000 cells/mm(^3) (in the absence of on-going G-CSF therapy - Platelet count 75,000/mm(^3) - AST <7.0 times the upper limit of normal - ALT ,7.0 times the upper limit of normal - Serum creatinine <1.1 times the upper limit of normal Exclusion Criteria - Evidence of active HBV infection as demonstrated by HBsAg positivity - Hepatitis C co-infection - Concurrent systemic antiviral treatment - Previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within 3 months of study start or the expected need for such therapy at study start. - Alcohol abuse - Pregnancy or breast-feeding - Inability to tolerate oral medication - AST > 7.0 times the upper limit of normal - ALT > 7.0 times the upper limit of normal - Any clinical condition or prior therapy that, in the Investigators opinion, would make the subject unsuitable for the study or unable to comply with the dosing requirements. - Use of any other drug or substance with anti-HBV activity
Total Enrollment: 60
Location and Contact Information:
Swedish Medical Center
Seattle, Washington, 98122
United States
Pacific Horizon Medical Group, Inc.
San Francisco, California, 94115
United States
Community Health Care Center One, Inc.
Ft. Lauderdale, Florida, 33306
United States
Stony Brook University Infectious Disease, Dept. of Medicine
Stony Brook, New York, 11794-8153
United States
South Shore Hospital
Miami, Florida, 33160
United States
Body Positive, Inc.
Phoenix, Arizona, 85006
United States
Hampton Road Medical Specialists
Hampton, Virginia, 23666
United States
St. Lukes Roosevelt Hospital
New York City, New York, 10019
United States
AIDS Research Consortium
Atlanta, Georgia, 30308
United States
Additional Information:
Study ID Numbers: ACH443-006;
Study Start Date:
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00040157
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Safety and antiviral study of ACH-126, 443 (beta-L-Fd4C) in the treatment of adults with HIV infection and modestly detectable viral load.
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