ART Drug Dosage Adjustment in HIV-infected Population

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine efficacy of the combination of low dose of Tenofovir, Efavirenz and Lamivudine in treating HIV-infection.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Public Health Clinical Center
• Treatments: Efavirenz; Lamivudine; Tenofovir

Criteria

Inclusion Criteria:

• HIV antibody positive

• HIV RNA below 10*E5 copies/ml

• CD4 T cell count above 200 cells/ml

• Provision of written informed consent

Exclusion Criteria:

• HIV genotyping resistant to investigating drug

• Pregnant, breastfeeding, or lactating

• Any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with treatment, assessment, compliance with the protocol, or subject safety. This would include any active clinically significant renal, cardiac, pulmonary, vascular, or metabolic (thyroid disorders, adrenal disease) illness, or malignancy

• Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol

• Laboratory blood values:

• Haemoglobin <7.0 grams/decilitre (g/dL)

• Neutrophil count <500/mm3

• Platelet count <50,000/mm3

• Aspartate aminotransferase or Alanine transaminase >5 times Upper Limit of Normal (ULN)

• Subjects with an estimated creatinine clearance of <50 mL/minute