ART Drug Dosage Adjustment in HIV-infected Population

Shanghai Public Health Clinical Center

Status and phase

Completed

Phase 4

Conditions

HIV Infections

Treatments

Drug: Tenofovir(TDF)+Lamivudine(3TC)+Efavirenz(EFV)

Study type

Interventional

Funder types

Other

Identifiers

NCT02632474

FSCII-ART-1

Details and patient eligibility

About

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

Full description

The feedback system control (FSC) technique has been developed to rapidly identify optimal combinations for therapeutic purposes. Low dose of TDF+3TC+EFV combination has been test in vitro study by FSC which showed high efficacy and now the investigators apply it to human to further optimize the ART combination.

Enrollment

10 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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