None listed
Conditions
Interventions
Group 1 Type of group
Apricitabine 800mg (2 capsules of 400 mg and 1 placebo capsule of lamivudine) orally for 48 weeks
Group name:Group 3 Type of group
lamivudine 150 mg BID (plus placebo of apricitabine), orally for 48 months
Sponsors
AVEXA LIMITED,
Eligibility
Inclusion criteria
Inclusion criteria: • HIV-I positive with mutation MI 84V / 1 in reverse transcriptase • 18 years of age or older • Stable ART regimen that contains either lamivudine (3TG) or emtrlcitabine (FTC) unchanged for at least 2 months before the baseline evaluation • Have received at least 2 kinds of antiretroviral drugs • HIV-1 RNA in plasma> 2000 copies / ml • CD4 + cell count without restrictions • Informed consent, in writing
Exclusion criteria
Exclusion criteria: • Infection by VIH-2 • Presence of Q151M or insertion 69 mutations in the reverse transcriptase of VlH-1 • Clinically relevant current or recurrent disease, pathology or abnormality of the laboratory, which is likely to require treatment during the study, which could affect the interpretation of efficacy assessment parameters, for example, HIV-1 RNA levels • Female patients with a positive pregnancy test or who are breastfeeding • Current active infection with the hepatitis B virus (HBV), (HBsAg positive and requiring treatment within the following 12 months) • HBV-infected patients, well controlled, who do not take tenofovir as part of the OBR and who are receiving adefovir dipivoxil for at least 30 days before selection, who meet the requirements of AST and ALT 3 times the LSN • Total bilirubin> 1.5 x ULN, with the exception of patients receiving atazanavir any other medication known to raise the level of indirect bilirubin, as long as the direct bilirubin is lower than the ULN. • Lipasa> 3 times the LSN • Amylase> 3 times the ULN (unless the serum lipase is ^ 1.5 times the ULN) • Estimated creatinine clearance (Gockcroft Gault) <50 ml / min • Patients who have previously received ATG.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Proportion of patients with plasma HIV-1 RNA <400 copies / ml in w24 Measure:Primary efficacy Timepoints:Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Proportion of patients with plasmatic RNA of VlH-1 <400 copies / ml in S48 Measure:Secondary efficacy Timepoints:Week 48 ; Outcome name:Time to loss of virological response (TLOVR analysis: FDA algorithm) in w12, w24 & w48 (<400 copies / ml) Measure:Time to loss of virological response Timepoints:Week 12, 24 and 48 ; Outcome name:Proportion of patients with plasma HIV-1 RNA <50 copies / ml in S24 and S48 Measure:Proportion of patients with plasma HIV-1 RNA <50 copies / ml in S24 and S48 Timepoints:Week 24 and 48 | — |
Countries
Belgium, France, Germany, Italy, Portugal, United Kindgdom
Contacts
Public ContactLuis Miguel Melendez
PPD Peru S.A.C.
Outcome results
None listed