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ART Drug Dosage Adjustment in HIV-infected Population

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Tenofovir(TDF)+Lamivudine(3TC)+Efavirenz(EFV)
Sponsored by
Shanghai Public Health Clinical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV Infections, Tenofovir, Efavirenz

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Public Health Clinical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Low-dose

Arm Description

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

Outcomes

Primary Outcome Measures

HIV viral load

Secondary Outcome Measures

CD4 Count

Full Information

First Posted
December 14, 2015
Last Updated
January 18, 2017
Sponsor
Shanghai Public Health Clinical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02632474
Brief Title
ART Drug Dosage Adjustment in HIV-infected Population
Official Title
ART Drug Dosage Adjustment Using FSCII in Chinese HIV-infected Population
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Public Health Clinical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV Infections, Tenofovir, Efavirenz

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-dose
Arm Type
Experimental
Arm Description
Tenofovir(TDF)+Lamivudine(3TC)+Efavirenz(EFV)
Intervention Type
Drug
Intervention Name(s)
Tenofovir(TDF)+Lamivudine(3TC)+Efavirenz(EFV)
Intervention Description
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).
Primary Outcome Measure Information:
Title
HIV viral load
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
CD4 Count
Time Frame
48 weeks
Other Pre-specified Outcome Measures:
Title
Drug Plasma Concentration
Time Frame
Day 7,14,21,28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201508
Country
China

12. IPD Sharing Statement

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ART Drug Dosage Adjustment in HIV-infected Population

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