Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With HIV Infection and Modestly Detectable Viral Load.
NCT ID: NCT00040157
Last Updated: 2015-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
60 participants
INTERVENTIONAL
2003-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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ACH126-443 (Beta-L-Fd4C)
Eligibility Criteria
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Inclusion Criteria
* 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:
* HGB≥9.0g/dl or HCT≥27% (in the absence of blood transfusions or erythropoietin treatment in the preceding two weeks
* Absolute neutrophil count≥1000 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
* 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
18 Years
ALL
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Locations
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Body Positive, Inc.
Phoenix, Arizona, United States
Los Angeles, California, United States
Pacific Horizon Medical Group, Inc.
San Francisco, California, United States
Community Health Care Center One, Inc.
Fort Lauderdale, Florida, United States
South Shore Hospital
Miami Beach, Florida, United States
AIDS Research Consortium
Atlanta, Georgia, United States
Chicago, Illinois, United States
St. Lukes Roosevelt Hospital
New York, New York, United States
Stony Brook University Infectious Disease, Dept. of Medicine
Stony Brook, New York, United States
Houston, Texas, United States
Houston, Texas, United States
Hampton Road Medical Specialists
Hampton, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Countries
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Related Links
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Related Info
Other Identifiers
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ACH443-006
Identifier Type: -
Identifier Source: org_study_id