ART Drug Dosage Adjustment in HIV-infected Population

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02632474
• Other study ID #: FSCII-ART-1
• Status: Completed
• Phase: Phase 4
• First received: December 14, 2015
• Last updated: January 18, 2017
• Start date: April 2015

Study information

• Verified date: January 2017
• Source: Shanghai Public Health Clinical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

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).

Locations

Country	Name	City	State
China	Shanghai Public Health Clinical Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Public Health Clinical Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Drug Plasma Concentration		Day 7,14,21,28
Primary	HIV viral load		48 weeks
Secondary	CD4 Count		48 weeks