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

AIDS/HIV PROBLEM Clinical Trial

Official title:

Efficacy and Safety of Tenofovir Disoproxil Fumarate Plus Lamivudine Plus Efavirenz Regimen as First-line Antiretroviral Therapy for ART-naive Chinese Patients With HIV-1 Infection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01844297
• Other study ID #: CACT1215
• Status: Not yet recruiting
• Phase: N/A
• First received: August 24, 2012
• Last updated: April 26, 2013
• Start date: May 2013
• Est. completion date: December 2015

Study information

• Verified date: April 2013
• Source: Peking Union Medical College
• Contact: Tai sheng Li, MD
• Phone: 86-10-69155086
• Email: litsh[@]263.net
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AIDS/HIV PROBLEM

Intervention

Drug:
• TDF+3TC+EFV

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48		48 weeks	No
Secondary	Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96		96 weeks	No
Secondary	Percentage of Participants With HIV-1 RNA < 40 Copies/mL at Week 96		96 weeks	No
Secondary	Change From Baseline in CD4 count at Week 48		Baseline and 48 weeks	No
Secondary	Change From Baseline in CD4 count at Week 96		Baseline and 96 weeks	No
Secondary	Incidence of adverse events and laboratory abnormalities from baseline to week 48		48 weeks	Yes
Secondary	Incidence of adverse events and laboratory abnormalities from baseline to week 96		96 weeks	Yes