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Report for Clinical Trial NCT00040157

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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.

NCT00040157 HIV Infections
MeSH: Infection HIV Infections Acquired Immunodeficiency Syndrome

1 Interventions

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

Type: Drug



Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 M184V

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. --- M184V ---

- Use of any other drug or substance with anti-HBV activity 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. --- M184V ---



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