Study of the Efficacy and Safety of Apricitabine, a New NRTI, to Treat Drug-resistant HIV Infectio
- Conditions
- -B24 Unspecified human immunodeficiency virus [HIV] diseaseUnspecified human immunodeficiency virus [HIV] diseaseB24
- Registration Number
- PER-021-08
- Lead Sponsor
- AVEXA LIMITED,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• 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
• 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 upper limit of the range normal (LSN), and continue with adefovir dipivoxil throughout the study, can enroll. Adefovir dipivoxil should not be prescribed concurrently with tenofovir in this study due to issues related to potential renal toxicity.
• Current treatment for infection with the hepatitis C virus, or requiring treatment within the next 12 months
• New AIDS marker disease (Category 0, Appendix 1) diagnosed within 42 days prior to the baseline assessment, with the exception of GD4 cells <200 / mm ^ Kaposi´s sarcoma (KS) confined to the skin and HIV cachexia , that is, not related to any other known cause
• Patients who, within the 42 days prior to the baseline evaluation, have received immunomodulatory agents, immunization, other than for influenza or pneumococcus, systemic chemotherapy agents, a prophylactic agent for HIV or immunotherapeutic vaccine
• Hemoglobin <10.0 g / dl for men and <9.0 g / dl for women
• Neutrophil count <750 / mm ^
• Platelet count <50,000 / mm ^
• AST or 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Proportion of patients with plasma HIV-1 RNA <400 copies / ml in w24<br>Measure:Primary efficacy<br>Timepoints:Week 24<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Proportion of patients with plasmatic RNA of VlH-1 <400 copies / ml in S48<br>Measure:Secondary efficacy<br>Timepoints:Week 48<br>;<br>Outcome name:Time to loss of virological response (TLOVR analysis: FDA algorithm) in w12, w24 & w48 (<400 copies / ml)<br>Measure:Time to loss of virological response<br>Timepoints:Week 12, 24 and 48<br>;<br>Outcome name:Proportion of patients with plasma HIV-1 RNA <50 copies / ml in S24 and S48<br>Measure:Proportion of patients with plasma HIV-1 RNA <50 copies / ml in S24 and S48<br>Timepoints:Week 24 and 48<br>