A Long Term Safety Study of Apricitabine in HIV-infected Patients

Not Applicable

Completed

• Conditions: -B24 Unspecified human immunodeficiency virus [HIV] disease; Unspecified human immunodeficiency virus [HIV] disease; B24

• Registration Number: PER-083-08
• Lead Sponsor: AVEXA LIMITED,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-12
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

• Patients who complete the AVX-301 or AVX-302 studies and who comply with the following: o Plasma HIV-1 RNA levels <2,000 copies / ml
• Patients who meet the criteria to receive ATC openly due to virogenic failure / lack of response in the AVX-301 or AVX-302 study, and to be removed from these studies for that reason, and to comply with the following: demonstration of presence of mutation M184V / 1, and absence of Q151M or of insertions 69, in the reverse transcriptase in the Selection.
• Unrestricted counting of CD4 + cells.
• 18 years of age, or older.
• Male or female patients who are not pregnant or breastfeeding, who agree to comply with the corresponding contraceptive requirements of the protocol.
• The patient must understand, be able to have wishes and in the same way comply with the procedures and restrictions of the study.
• Written / manifest informed consent to participate in the study before performing any of the procedures related to the study.

Exclusion Criteria

• Patients admitted to the AVX-304 study.
• Considered by the Investigator that possibly does not comply with the TAR (RRO or product under investigation).
• Violation (s) greater than the protocol documented during the AVX-301 or AVX-302 study including lack of compliance with the study medication and / or the RRO.
• Previous removal of the AVX-301 or AVX-302 study for any reason. Patients who wish to withdraw from the AVX-301 or AVX-302 study and enter the AVX-303 study due to virological failure or lack of response defined by protocol should continue in the AVX-301 or AVX-302 studies. until the selection for the AVX-303 study has been completed and eligibility confirmed.
• Patients who were previously admitted to this study and who were later withdrawn.
• Current to chronic infection with the hepatitis B virus (HBsAg positive and requiring treatment in the next 12 months).
• Current treatment for infection with hepatitis C virus or similar treatment within 12 months.
• Serious, serious or unstable physical or psychiatric illness (acute or progressive), any clinical disorder that may require treatment or make the patient may not be able to completely comply with the study, or any pathology that presents an excessive risk for the product in investigation or procedures, current or with important previous antecedents, as determined by the researcher. Also, any current or recurrent disease or intolerance to the investigational product that could affect the action, absorption or distribution, metabolism, or elimination of the product under investigation, or clinical or laboratory evaluations, as determined by the Investigator.
• Important clinical abnormalities of medical history, physical examination, or laboratory parameters (hematology, biochemistry, urinalysis).
• Patients with abnormality of any of the following clinical laboratory tests in the Selection: a. hemoglobin <10.0 g / dl in men and <9.0 g / dl in women b. Neutrophil count <750 / mm3 c. platelet count <50,000 / mm3 d. AST or ALT> 3 times the upper limit of normality (ULN for its acronym in English, upper limit of normal) e. total bilirubin> 1.5 x ULN, except for patients who are receiving atazanavir or any other medication, which is known to increase the concentration of indirect bilirubin as long as the direct bilirubin is lower than the ULN f. lipase> 3 times the ULN g. amylase> 3 times the ULN (unless the serum lipase is <1.5 times the ULN) h. Calculated creatinine clearance <50ml / min
• The patient has, at the discretion of the Investigator, a dependence on alcohol or other abuse of a substance within 6 months of the Selection.
• Active, serious infections (other than HIV infection -1) that require antimicrobial or antiparasitic therapy parenterally within 15 days before the Selection.
• Female patients with a positive pregnancy test in the Selection or Baseline evaluation, or who are breastfeeding, or who plan to become pregnant during the duration of the study and any follow-up.

Study & Design

• Study Type: Interventional
• Study Design: Not specified