A 14-DAY, RANDOMIZED, DOUBLE-BLIND, COMPARATIVE VIRAL KINETIC STUDY OF ELVUCITABINE VERSUS LAMIVUDINE ADMINISTERED ONCE DAILY TO HIV-1 INFECTED SUBJECTS WITH A DOCUMENTED M184V VARIANT - ND

• Conditions: HIV; MedDRA version: 9.1Level: LLTClassification code 10049826Term: Blood HIV RNA

• Registration Number: EUCTR2006-005968-13-IT
• Lead Sponsor: ACHILLION PHARMACEUTICALS, INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. HIV-1-infected, clinically stable with no AIDS-defining events 2. Adults, aged 18 years - 65 years 3. Sexually active men with partners of childbearing potential and women of childbearing potential (WOCBP, 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 determined by the investigator) during participation in the study and for 30 days after the last dose of study drug 4. Plasma HIV-1 RNA levels 5,000 - 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 greater or equal to 100 cells/mL 9. Acceptable hematologic and chemistry parameters as follows: Hemoglobin greater or equal to 11 g/dL Absolute neutrophil count (ANC) greater or equal to 2000 cells/mm3 Platelets greater or equal to 100,000 cells/mm3 Alanine transaminase (ALT)/aspartate transaminase (AST) greaer or equal to 1.5 times the upper normal limit (UNL) Bilirubin ≤ 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

1. Hepatitis B surface antigen (HBsAg) positive, and/or HBV DNA positive 2. HIV-1 genotype positive for greater or equal to 4 protease primary mutations 3. HIV-1 genotype positive for greater or equal to 2 non-nucleoside reverse transcriptase inhibitors mutations 4. 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 5. Previous use or need for bone marrow colony stimulating factors such as erythropoietin (Epogen or Procrit) or filgrastim (Neupogen), etc 6. Evidence or history of cirrhosis 7. Recent (within 3 months of screening) history of alcohol abuse, physical dependence to any opioid, cocaine, LSD or amphetamines, or history of drug addiction 8. Inability to tolerate oral medication 9. Woman who are pregnant or breastfeeding 10. 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 11. 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified