Chronic Human Immunodeficiency Virus (HIV-1) Infection MedDRA version: 9.1 Level: LLT Classification code 10008919 Term: Chronic HIV infection
Conditions
Sponsors
Achillion Pharmaceuticals, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. HIV-1-infected, clinically stable with no AIDS-defining events 2. Adults, aged NLT 18 years and NMT 65 years 3. Sexually active men with partners of childbearing potential and women of childbearing potential (WOBCP; defined as a woman biologically capable of becoming pregnant; includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives) must agree to use an acceptable form of contraception (as defined in the protocol) during participation in the study and for 30 days after the last dose of test drug. 4. Plasma HIV-1 RNA levels NLT 2,000 and NMT 150,000 copies/mL at screening (Amplicor HIV-1 Monitor Test, version 1.5, Roche Diagnostic) 5. Genotypically documented M184V variant as assessed by a Trugene HIV-1 kit 6. Positive HIV-1 genotype for K103N if currently receiving Efavirenz or Nevirapine 7. Receiving a stable antiretroviral regimen (defined as no change in antiretroviral therapy for at least 4 weeks prior to randomization) that includes lamivudine or emtricitabine 8. CD4 count of NLT 100 cells/mL 9. Acceptable hematologic and chemistry parameters as follows: - Hemoglobin NLT 11 g/dL - Absolute neutrophil count (ANC) NLT 2000 cells/mm3 - Platelets NLT 100,000 cells/mm3 - Alanine transaminase (ALT)/ aspartate transaminase (AST) NMT 1.5 times the upper normal limit (UNL) - Bilirubin NMT 1.5 times UNL 10. Subjects must be able to provide written informed consent prior to screening. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Hepatitis B surface antigen (HBsAg) positive, and/or HBV DNA positive with NLT 316 U/mL 2. HIV-1 genotype positive for NLT 4 protease primary mutations 3. HIV-1 genotype positive for NLT 2 non-nucleoside reverse transcriptase inhibitor (NNRTI) mutations. Subjects who are on efavirenz or nevirapine can have 1 additional NNRTI mutation aside from the K103N. 4. HIV-1 genotype positive for NLT 3 TAM mutations other than the M184V mutation. 5. Previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within 3 months of Study Day 1 or the expected need for such therapy after Study Day 1 6. Previous use or need for bone marrow colony stimulating factors such as erythropoietin (Epogen or Procrit) or filgrastim (Neupogen), etc 7. Evidence or history of cirrhosis 8. Recent (within 3 months of screening) history of alcohol abuse, physical dependence to any opioid, cocaine, LSD or amphetamines, or history of drug addiction 9. Inability to tolerate oral medication 10. Woman who are pregnant or breastfeeding 11. Abnormal renal function, defined as serum creatinine NLT 1.0 ULN or calculated creatinine clearance NMT 60 mL/min using the Cockcroft-Gault formula, as summarized in the protocol 12. Any clinical condition or prior therapy that, in the investigator’s opinion, would make them unsuitable for the study or unable to comply with the dosing requirements 13. Participated in a clinical study involving administration of an investigational drug (new chemical entity), or a marketed drug within the past 30 days of Study Day 1 14. Subjects who have a history of hypersensitivity to elvucitabine or any of its components, or to lamivudine or any of its components
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) To assess the viral kinetics of 10 mg of elvucitabine administered once daily (QD) for 14 days in combination with background antiretroviral therapy in HIV-1-infected subjects with a documented M184V variant. 2) To demonstrate the anti-viral activity of 10 mg of elvucitabine administered QD for 14 days in combination with background antiretroviral therapy as compared with lamivudine in combination with background antiretroviral therapy in HIV-1 infected subjects with a documented M184V variant. 3) To assess the safety of elvucitabine therapy in HIV-1 infected subjects with a documented M184V variant. ;Secondary Objective: None;Primary end point(s): The primary efficacy endpoint will be defined as a log fall equal to or more than 0.5 in HIV-1 RNA levels from baseline to Day 14. The primary measures to assess the safety profile will be determined by the incidence of treatment discontinuations, the incidence of SAEs during the study, the profile of all clinical and laboratory AEs during the study, and the profile of HIV-1 genotypic and phenotypic changes over the treatment period. | — |
Countries
Germany, Italy, Spain
Outcome results
None listed