ART Drug Dosage Adjustment in HIV-infected Population

January 18, 2017 updated by: Hongzhou Lu, Shanghai Public Health Clinical Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HIV viral load
Time Frame: 48 weeks
48 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
CD4 Count
Time Frame: 48 weeks
48 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Drug Plasma Concentration
Time Frame: Day 7,14,21,28
Day 7,14,21,28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Public Health Clinical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

December 14, 2015

First Submitted That Met QC Criteria

December 14, 2015

First Posted (ESTIMATE)

December 16, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

January 19, 2017

Last Update Submitted That Met QC Criteria

January 18, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSCII-ART-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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