Clinical Trials

MainTitle

ART Drug Dosage Adjustment in HIV-infected Population

This study has been completed
Sponsor
Shanghai Public Health Clinical Center


Information provided by (Responsible Party)
Hongzhou Lu, Shanghai Public Health Clinical Center

ClinicalTrials.gov Identifier
NCT02632474

First received: December 14, 2015
Last updated: January 18, 2017
Last Verified: January 2017
History of Changes
Purpose

Purpose

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

Condition Intervention Phase
HIV Infections

Drug : Tenofovir(TDF)+Lamivudine(3TC)+Efavirenz(EFV)
Phase 4

Study Type: Interventional
Study Design: Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ART Drug Dosage Adjustment Using FSCII in Chinese HIV-infected Population

Further study details as provided by Hongzhou Lu, Shanghai Public Health Clinical Center:

Primary Outcome Measures

  • HIV viral load [ Time Frame: 48 weeks ]
Secondary Outcome Measures:
  • CD4 Count [ Time Frame: 48 weeks ]
Other Outcome Measures:
  • Drug Plasma Concentration [ Time Frame: Day 7,14,21,28 ]

Enrollment: 10
Study Start Date: April 2015
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Low-dose
Tenofovir(TDF)+Lamivudine(3TC)+Efavirenz(EFV)
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).

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 65 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02632474

Locations

China
Shanghai Public Health Clinical Center
Shanghai, Shanghai, China, 201508

Sponsors and Collaborators

Shanghai Public Health Clinical Center
More Information

More Information


Responsible Party: Hongzhou Lu, Doctor, Shanghai Public Health Clinical Center  
ClinicalTrials.gov Identifier: NCT02632474   History of Changes  
Other Study ID Numbers: FSCII-ART-1  
Study First Received: December 14, 2015  
Last Updated: January 18, 2017  

Keywords provided by Hongzhou Lu, Shanghai Public Health Clinical Center:

HIV Infections
Tenofovir
Efavirenz

Additional relevant MeSH terms:
HIV Infections
Tenofovir
Lamivudine
Efavirenz

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.