Dosing of Tenofovir and Efavirenz in Antiretroviral Therapy

NCT ID: NCT02945163

Last Updated: 2020-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-05
• Study Completion Date: 2019-08-31

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

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

Group Type: EXPERIMENTAL

Tenofovir

Intervention Type: DRUG

Tenofovir Disoproxil Fumarate

Lamivudine

Intervention Type: DRUG

Lamivudine

Efavirenz

Intervention Type: DRUG

Efavirenz

Arm 2

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

Group Type: ACTIVE_COMPARATOR

Tenofovir

Intervention Type: DRUG

Tenofovir Disoproxil Fumarate

Lamivudine

Intervention Type: DRUG

Lamivudine

Efavirenz

Intervention Type: DRUG

Efavirenz

Interventions

Tenofovir

Tenofovir Disoproxil Fumarate

Intervention Type: DRUG

Lamivudine

Lamivudine

Intervention Type: DRUG

Efavirenz

Efavirenz

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Hospital of Nanjing Medical University

OTHER

Sponsor Role: collaborator

Yunnan Provincial Infectious Disease Hospital

OTHER

Sponsor Role: collaborator

Shanghai Public Health Clinical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Hongzhou Lu

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Second Hospital of Nanjing

Nanjing, Jiangsu, China

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Yunnan provincial infectious disease hosipital

Kunming, Yunnan, China

Countries

China

Other Identifiers

2016-M-2

Identifier Type: -

Identifier Source: org_study_id