Dosing of Tenofovir and Efavirenz in Antiretroviral Therapy

The Optimization of HAART for Chinese--a RCT Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02945163

Enrollment

184

Registered

2016-10-26

Start date

2018-03-05

Completion date

2019-08-31

Last updated

2020-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

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.

Interventions

DRUGTenofovir

Tenofovir Disoproxil Fumarate

DRUGLamivudine

Lamivudine

DRUGEfavirenz

Efavirenz

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Percentage of patients with HIV RNA<50 Copies/ml	48 weeks

Secondary

Measure	Time frame
Adverse events	48 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026