Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With HIV Infection and Modestly Detectable Viral Load. - Tabular View

Tracking Information
First Received Date ^ICMJE	June 21, 2002
Last Updated Date	August 18, 2009
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00040157 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With HIV Infection and Modestly Detectable Viral Load.
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: ACH126-443 (Beta-L-Fd4C)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	60
Completion Date	May 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00040157
Responsible Party
Study ID Numbers ^ICMJE	ACH443-006
Study Sponsor ^ICMJE	Achillion Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Achillion Pharmaceuticals
Verification Date	August 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP