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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.

This study has been terminated.
(Safety concerns)
Sponsor:
Information provided by:
Achillion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00040157
First received: June 21, 2002
Last updated: August 18, 2009
Last verified: August 2009

June 21, 2002
August 18, 2009
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Complete list of historical versions of study NCT00040157 on ClinicalTrials.gov Archive Site
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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.
A Phase 2 Trial of 4 Weeks of ACH-126,443 in Comparison With Continued Lamivudine in Stable Triple Antiretroviral Combination Therapy in HIV-Infected Subjects With Modestly Detectable Viral Load

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
Drug: ACH126-443 (Beta-L-Fd4C)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
May 2003
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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:
  • 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

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00040157
ACH443-006
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Achillion Pharmaceuticals
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Achillion Pharmaceuticals
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP