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Dosing of Tenofovir and Efavirenz in Antiretroviral Therapy

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Tenofovir
Lamivudine
Efavirenz
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

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HIV antibody positive
  • Chinese nationality
  • Naïve to antiretroviral therapy
  • Willing to start antiretroviral therapy
  • Provision of written informed consent

Exclusion Criteria:

  • Pregnant, breastfeeding, or lactating
  • Females try to get pregnant during the research period
  • Subjects who allergic to any of the research drugs
  • Subjects that taking other drugs that known to impact the absorption, distribution, metabolism and excretion of the research drugs
  • 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 <9.0 grams/decilitre (g/dL)
  • Neutrophil count <1500/mm3
  • Platelet count <75,000/mm3
  • Aspartate aminotransferase or Alanine transaminase >3 times Upper Limit of Normal (ULN)
  • Total bilirubin >3 times Upper Limit of Normal (ULN)
  • Subjects with an estimated creatinine clearance of <90 mL/minute

Sites / Locations

  • The Second Hospital of Nanjing
  • Shanghai Public Health Clinical Center
  • Yunnan provincial infectious disease hosipital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Tenofovir 200mg + Lamivudine 300mg +Efavirenz 400mg PO Quaque die

Tenofovir 300mg + Lamivudine 300mg +Efavirenz 600mg PO Quaque die

Outcomes

Primary Outcome Measures

Percentage of patients with HIV RNA<50 Copies/ml

Secondary Outcome Measures

Adverse events

Full Information

First Posted
October 25, 2016
Last Updated
February 16, 2020
Sponsor
Shanghai Public Health Clinical Center
Collaborators
The Second Hospital of Nanjing Medical University, Yunnan Provincial Infectious Disease Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02945163
Brief Title
Dosing of Tenofovir and Efavirenz in Antiretroviral Therapy
Official Title
The Optimization of HAART for Chinese--a RCT Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 5, 2018 (Actual)
Primary Completion Date
June 5, 2019 (Actual)
Study Completion Date
August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Public Health Clinical Center
Collaborators
The Second Hospital of Nanjing Medical University, Yunnan Provincial Infectious Disease Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Tenofovir+lamivudine+efavirenz is still the first line regimen of combination antiretroviral therapy in developing countries. Based on our previous data, we aim to evaluate whether reduce the dose of tenofovir and efavirenz could decreasing the incidence of the side effects while not scarifying their virological efficacy.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Tenofovir 200mg + Lamivudine 300mg +Efavirenz 400mg PO Quaque die
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Tenofovir 300mg + Lamivudine 300mg +Efavirenz 600mg PO Quaque die
Intervention Type
Drug
Intervention Name(s)
Tenofovir
Intervention Description
Tenofovir Disoproxil Fumarate
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Description
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Efavirenz
Intervention Description
Efavirenz
Primary Outcome Measure Information:
Title
Percentage of patients with HIV RNA<50 Copies/ml
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV antibody positive Chinese nationality Naïve to antiretroviral therapy Willing to start antiretroviral therapy Provision of written informed consent Exclusion Criteria: Pregnant, breastfeeding, or lactating Females try to get pregnant during the research period Subjects who allergic to any of the research drugs Subjects that taking other drugs that known to impact the absorption, distribution, metabolism and excretion of the research drugs 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 <9.0 grams/decilitre (g/dL) Neutrophil count <1500/mm3 Platelet count <75,000/mm3 Aspartate aminotransferase or Alanine transaminase >3 times Upper Limit of Normal (ULN) Total bilirubin >3 times Upper Limit of Normal (ULN) Subjects with an estimated creatinine clearance of <90 mL/minute
Facility Information:
Facility Name
The Second Hospital of Nanjing
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210003
Country
China
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201508
Country
China
Facility Name
Yunnan provincial infectious disease hosipital
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650041
Country
China

12. IPD Sharing Statement

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Dosing of Tenofovir and Efavirenz in Antiretroviral Therapy

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