HIV-1 MedDRA version: 9.1 Level: LLT Classification code 10064446 Term: HIV infection WHO clinical stage I
Conditions
Sponsors
Avexa Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for inclusion, each patient must fulfil each of the following criteria at Screening: 1. 18 years of age, or older. 2. Male, or non-pregnant, non-breastfeeding female patients, who agree to comply with the applicable contraceptive requirements of the protocol 3. Documented laboratory diagnosis of HIV-1 infection (positive ELISA HIV-1 antibody test confirmed by Western Blot, p24 assay, HIV-1 RNA, or culture); if no record exists, must be tested at screening. 4. Currently receiving stable ART regimen comprising at least three drugs, and containing either lamivudine or emtricitabine that is unchanged for at least 2 months prior to first dose of Investigational Product. 5. Plasma HIV-1 RNA levels =2,000 copies/mL at Screening using the Roche Cobas Ampliprep / Cobas Taqman (dynamic range 40-10,000,000 copies per mL) performed at the central laboratory. 6. Presence of the M184V/I mutation in reverse transcriptase at Screening. 7. Unrestricted CD4+ cell count. 8. The patient must understand and be able, willing and likely to fully comply with study procedures and restrictions. 9. Written/marked, informed consent to participate in the study prior to the conduct of any study related procedures. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if any of the following criteria are met at Screening: 1. Previous documented laboratory diagnosis of HIV-2 infection 2. Presence of Q151M or 69 insertion mutations in reverse transcriptase. 3. Considered to be significantly and chronically ART non-compliant by the Investigator. 4. Current or recurring disease that could affect the action, absorption or disposition of the Investigational Product, or clinical or laboratory assessments, as determined by the investigator. 5. Current acute or chronic Hepatitis B virus infection (HBsAg positive and requiring treatment in the next 12 months). - Previous, resolved HBV infection is permitted. - Well controlled HBV-infected patients not taking tenofovir as part of the OBR and who have been receiving adefovir dipivoxil for at least 30d prior to screening, who meet the requirements for AST and ALT 1.5 x ULN, with the exception of patients receiving atazanavir or any other medication known to elevate the indirect bilirubin level as long as the direct bilirubin is less than the ULN. f. Lipase >3 times ULN g. Amylase >3 times ULN (unless serum lipase is ? 1.5 times ULN) h. Estimated Creatinine Clearance <50mL/min (estimated by Cockcroft and Gault equation) 11. Known or suspected intolerance or hypersensitivity to ATC, lamivudine or any of the stated ingredients 12. The patient has, in the opinion of the Investigator, a dependence on alcohol or other substance abuse within 6 months of Screening that will likely interfere with study compliance and/or make difficult the objective interpretation of clinical and/or laboratory data. 13. Active, serious infections (other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To compare the antiretroviral efficacy of ATC to lamivudine (3TC) in treatment experienced, HIV-1 infected patients with the M184V/I mutation in reverse transcriptase. •To compare the safety and tolerability of ATC to lamivudine (3TC) in treatment experienced, HIV-1 infected patients. ;Secondary Objective: •To compare the effect of ATC vs. 3TC upon CD4+ and CD8+ T-cell counts. •To investigate the influence of increasing nucleoside associated mutations (NAMs) in reverse transcriptase upon the antiretroviral efficacy of ATC. •To investigate the emergence of ATC-associated HIV-1 resistance mutations. ;Primary end point(s): The primary efficacy endpoint is defined as the proportion of patients with plasma HIV-1 RNA <400 copies/mL at W24. | — |
Countries
Belgium, France, Germany, Italy, Portugal, United Kingdom
Outcome results
None listed