ART Drug Dosage Adjustment in HIV-infected Population | NCT02632474

Studies
ART Drug Dosage Adjustment in HIV-infected Population

NCT02632474

Sponsor

Shanghai Public Health Clinical Center

Status

Completed

Last Update Posted

Jan 19, 2017Estimated

Enrollment

10Actual

Phase

Phase 4

Conditions

HIV Infections

Interventions

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

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Dec 2016Actual

Completion Date

Not provided

First Submitted Date

Dec 14, 2015

First Submission Date that Met QC Criteria

Dec 14, 2015

First Posted Date

Dec 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2017

Last Update Posted Date

Jan 19, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low-dose	Experimental	Tenofovir(TDF)+Lamivudine(3TC)+Efavirenz(EFV)	Drug: Tenofovir(TDF)+Lamivudine(3TC)+Efavirenz(EFV)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tenofovir(TDF)+Lamivudine(3TC)+Efavirenz(EFV)	Drug	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).

Measure	Description	Time Frame
HIV viral load		48 weeks

Measure	Description	Time Frame
CD4 Count		48 weeks

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Public Health Clinical Center		Shanghai	Shanghai Municipality	201508	China

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

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