Overview

This trial is active, not recruiting.

Condition hiv infections
Treatment tenofovir(tdf)+lamivudine(3tc)+efavirenz(efv)
Phase phase 4
Sponsor Shanghai Public Health Clinical Center
Start date April 2015
End date December 2016
Trial size 10 participants
Trial identifier NCT02632474, FSCII-ART-1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Tenofovir(TDF)+Lamivudine(3TC)+Efavirenz(EFV)
tenofovir(tdf)+lamivudine(3tc)+efavirenz(efv)
The first 2 weeks, TDF (300 mg) + 3-TC (300 mg) + EFV (400 mg); week 3, TDF (200 mg) + 3-TC (300 mg) + EFV (400 mg ); week 4, TDF (150 mg) + 3-TC (300 mg) + EFV (400 mg).From week5, if the HIV viral load decreased as expected or no rebound, use TDF (200 mg) + 3-TC (300 mg) + EFV (400 mg) until study complete; if the viral load increases, switch to the standard treatment regimen: TDF (300 mg) + 3-TC (300 mg) + EFV (600 mg).

Primary Outcomes

Measure
HIV viral load
time frame: 48 weeks

Secondary Outcomes

Measure
CD4 Count
time frame: 48 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title ART Drug Dosage Adjustment Using FSCII in Chinese HIV-infected Population
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Shanghai Public Health Clinical Center.