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

NCT01844297 | Unknown DMC

• 1 other identifier: CACT1215
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

AIDS/HIV PROBLEM

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48

  48 weeks

Secondary Outcomes (6)

• 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

• Change From Baseline in CD4 count at Week 48

  Baseline and 48 weeks

• Change From Baseline in CD4 count at Week 96

  Baseline and 96 weeks

• Incidence of adverse events and laboratory abnormalities from baseline to week 48

  48 weeks

Study Arms (1)

TDF+3TC+EFV

OTHER

Drug: TDF+3TC+EFV

Interventions

TDF+3TC+EFV DRUG

TDF+3TC+EFV

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patients in acute phase of HIV infection
• 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

Sponsors & Collaborators

• Peking Union Medical College: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (2)

• 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.

  PMID: 32487185 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.

  PMID: 30871484 DERIVED

Central Study Contacts

Tai sheng Li, MD

CONTACT

86-10-69155086; litsh@263.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of the Department of Infectious Disease

Study Record Dates

• First Submitted: August 24, 2012
• First Posted: May 1, 2013
• Study Start: May 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 1, 2013

Record last verified: 2013-04

Locations

CN (1)