NCT02632474

ART Drug Dosage Adjustment in HIV-infected Population

ART Drug Dosage Adjustment Using FSCII in Chinese HIV-infected Population

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Shanghai Public Health Clinical Center · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	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).

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-12-01
• First posted: 2015-12-16
• Last updated: 2017-01-19

Locations

1 site across 1 country: China