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. (a) Patients who complete studies AVX-301 or AVX-302 and fulfill the following criteria: - Plasma HIV-1 RNA levels =2,000 copies/mL - Patients with plasma HIV-1 RNA levels >2,000 copies/mL should be discussed on an individual basis with the Sponsor. or (b) Patients who meet the criteria for open-label access to ATC because of virologic failure/lack of response in study AVX-301 or AVX-302, and who are withdrawn from those studies for that reason, and who fulfill the following criteria: - Demonstration of presence of M184V/I mutation, and absence of Q151M or 69 insertions, in reverse transcriptase at Screening. Note: Virologic failure is defined as the HIV-1 RNA level increasing by >1.0 log10 copies/mL (confirmed on two separate occasions at least one week apart) from the nadir value recorded during the study. 2. Unrestricted CD4+ cell count. 3. 18 years of age, or older. 4. Male, or non-pregnant, non-breastfeeding female patients, who agree to comply with the applicable contraceptive requirements of the protocol. 5. The patient must understand and be able, willing and likely to fully comply with study procedures and restrictions. 6. 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. Patients enrolled in study AVX-304. 2. Considered unlikely to be ART compliant (OBR or investigational product) by the Investigator. 3. Documented major protocol violation(s) during AVX-301 or AVX-302 including noncompliance with study medication and/or OBR. 4. Prior withdrawal from AVX-301 or AVX-302 for any reason. Patients who wish to withdraw from AVX-301 or AVX-302 and enter AVX-303 on the grounds of protocol-defined virologic failure or lack of response must continue in AVX-301 or AVX-302 until screening for AVX-303 is complete and eligibility confirmed. 5. Patients who have previously been enrolled into this study and subsequently withdrawn. 6. Current acute or chronic hepatitis B virus infection (HBsAg positive and requiring treatment in the next 12 months). a. Previous, resolved HBV infection (HBsAg seronegative with seropositivity for IgG-anti-HBc and/or anti-HBs antibodies) is permitted. b. Well controlled HBV-infected patients not taking tenofovir as part of the OBR who have been receiving adefovir dipivoxil continuously since at least 30 days prior to screening in AVX-301, 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. The patient has, in the opinion of the Investigator, a dependence on alcohol or other substance abuse within 6 months of Screening. 12. Active, serious infections (other than HIV-1 infection) requiring parenteral antimicrobial or antiparasitic therapy within 15 days prior to Screening. 13. Female patients with a positive pregnancy test at Screening or Baseline, or who are breastfeeding, or who plan to become pregnant during the duration of the study and any follow up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To investigate the long-term safety and tolerability of ATC in treatment-experienced HIV-1 infected patients.;Secondary Objective: ;Primary end point(s): The primary efficacy endpoint is defined as the safety and tolerability of ATC in treatment-experienced HIV-1 infected patients. | — |
Countries
Belgium, France, Germany, United Kingdom
Outcome results
None listed