ART Drug Dosage Adjustment in HIV-infected Population

NCT ID: NCT02632474

Last Updated: 2017-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low-dose

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Public Health Clinical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Hongzhou Lu

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

FSCII-ART-1

Identifier Type: -

Identifier Source: org_study_id