Optimization of Antiretroviral Therapy

Shanghai Public Health Clinical Center3 sites in 1 country184 target enrollmentMarch 5, 2018

ConditionsHIV Infections

InterventionsTenofovir disoproxil fumarate Lamivudine Efavirenz

DrugsTenofovir disoproxil fumarate Lamivudine Efavirenz

Overview

Phase: Phase 4
Intervention: Tenofovir disoproxil fumarate
Conditions: HIV Infections
Sponsor: Shanghai Public Health Clinical Center
Enrollment: 184
Locations: 3
Primary Endpoint: Percentage of patients with HIV viral road < 50 copies/ml
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The combination antiretroviral therapy (cART) inhibit HIV replication effectively. However, synergy among these drugs has not been well considered. The dose of drugs used as monotherapy is the same as that used in combination therapy. Tenofovir+lamivudine+efavirenz is still the first line regimen of cART in developing countries. The side effects of these drugs are related to the concentration of drugs. 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.

Registry

clinicaltrials.gov

Start Date

March 5, 2018

End Date

August 31, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai Public Health Clinical Center

Responsible Party

Principal Investigator

Hongzhou Lu

Doctor

Shanghai Public Health Clinical Center

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