Efficacy and Safety of Tenofovir Plus Lamivudine Plus Efa... | NCT01844297

Studies
Efficacy and Safety of Tenofovir Plus Lamivudine Plus Efavirenz Regimen as First-line Antiretroviral Therapy

NCT01844297

Sponsor

Peking Union Medical College

Status

Unknown status

Last Update Posted

May 1, 2013Estimated

Enrollment

500Estimated

Phase

Not Applicable

Conditions

AIDS/HIV PROBLEM

Interventions

TDF+3TC+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

Apr 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Oct 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Aug 24, 2012

First Submission Date that Met QC Criteria

Apr 26, 2013

First Posted Date

May 1, 2013Estimated

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

Apr 26, 2013

Last Update Posted Date

May 1, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This study aims to evaluate the safety and effectiveness of the tenofovir disoproxil fumarate (TDF) + lamivudine (3TC) + efavirenz (EFV) regimen in antiretroviral therapy (ART)-naive Chinese HIV/AIDS patients.

Detailed Description

This study is a prospective, open-label, multi-centered clinical trial to assess the virologic suppression and immune recovery rates as well as tolerability of the regimen 3TC+TDF+EFV in ARV-naive Chinese population.

500 eligible participants will be recruited to take the regimen If the patient fails to tolerate EFV, it can be substituted by NVP when CD4 < 250/μL, and by LPV/r when CD4 > 250/uL. If the patient fails to tolerate TDF, AZT will be an alternative, except when Hb < 90/L or neutrophil count < 0.75×109/L. The participants will be followed up by months 0.5, 1, 2 ,3 and every 3 months subsequently for 2 years.

The efficacy of the regimen will be evaluated by comparison between different points along the time line and previous regimens. The safety of the regimen will be assessed by monitoring kidney function, bone density, cardiovascular profile, lipid profile, liver function etc as well as other adverse events.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Label	Type	Description	Intervention Names
TDF+3TC+EFV	Other		Drug: TDF+3TC+EFV

Name	Type	Description	Arm Group Labels	Other Names
TDF+3TC+EFV	Drug		TDF+3TC+EFV

Measure	Description	Time Frame
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48		48 weeks

Measure	Description	Time Frame
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96		96 weeks
Percentage of Participants With HIV-1 RNA < 40 Copies/mL at Week 96		96 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age between 18-65 years of either gender
HIV-1 antibody seropositive detected by ELISA and confirmed by western blot
CD4 cell count < 500/ul
Signed informed consent, with no condition that precludes follow-up for 2 years
No plan to move out of the area during the trial
antiretroviral therapy naive

Exclusion Criteria:

patients in acute phase of HIV infection
patients with ongoing opportunistic infection or AIDS-related malignancies; or with opportunistic infection within previous 3 months and still unstable within 14 days before inclusion
patients with the any of the following test results during screening for inclusion:
- WBC count < 2000/ul,
- neutrophil count < 1000/ul,
- Hb < 9g/dl,
- platelet count < 75000/ul,
- serum creatinine > 1.5 ULN,
- transaminases or alkaline phosphatase > 3 ULN,
- total bilirubin > 2 ULN,
- serum creatinine kinase > 2 ULN
CCr < 60ml/min
Pregnancy and breastfeeding
Intravenous drug user
Severe neuropathy or mental disorder
history of alcohol abuse and unable to withdrawal
Severe peptic ulcer disease
Non-Chinese nationality

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

Name	Role	Phone	Extension	Email
Tai sheng Li, MD	Contact	86-10-69155086		litsh@263.net

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital		Beijing	Beijing Municipality	100730	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32487185	Derived	Fan H, Guo F, Hsieh E, Chen WT, Lv W, Han Y, Xie J, Li Y, Song X, Li T. Incidence of hypertension among persons living with HIV in China: a multicenter cohort study. BMC Public Health. 2020 Jun 1;20(1):834. doi: 10.1186/s12889-020-08586-9.
30871484	Derived	Luo L, Wang N, Yue Y, Han Y, Lv W, Liu Z, Qiu Z, Lu H, Tang X, Zhang T, Zhao M, He Y, Shenghua H, Wang M, Li Y, Huang S, Li Y, Liu J, Tuofu Z, Routy JP, Li T. The effects of antiretroviral therapy initiation time on HIV reservoir size in Chinese chronically HIV infected patients: a prospective, multi-site cohort study. BMC Infect Dis. 2019 Mar 14;19(1):257. doi: 10.1186/s12879-019-3847-0.