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

• Status: Terminated
• Trial end date: 2003-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Achillion Pharmaceuticals; Alexion Pharmaceuticals
• Treatments: Dexelvucitabine

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