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

Alexion Pharmaceuticals

Status and phase

Terminated

Phase 2

Conditions

HIV Infections

Treatments

Drug: ACH126-443 (Beta-L-Fd4C)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00040157

ACH443-006

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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:
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