NCT02935075

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P75+ for phase_4 hiv-infections

Timeline
Completed

Started Mar 2018

Shorter than P25 for phase_4 hiv-infections

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2016

Completed
1.4 years until next milestone

Study Start

First participant enrolled

March 5, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

1.3 years

First QC Date

October 14, 2016

Last Update Submit

February 16, 2020

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with HIV viral road < 50 copies/ml

    calculate the percentage of patients who with HIV viral road \<50 copies/ml every month in two groups

    48 weeks

Secondary Outcomes (1)

  • Cell Differentiation 4 (CD4) T cell counts

    48 weeks

Other Outcomes (1)

  • The incidence of adverse events

    48 weeks

Study Arms (2)

Reduced dose

EXPERIMENTAL

Tenofovir 200mg +lamivudine 300mg +efavirenz 400mg PO q.d.

Drug: Tenofovir disoproxil fumarateDrug: LamivudineDrug: Efavirenz

Standard dose

ACTIVE COMPARATOR

Tenofovir 300mg +lamivudine 300mg +efavirenz 600mg PO q.d.

Drug: Tenofovir disoproxil fumarateDrug: LamivudineDrug: Efavirenz

Interventions

Tenofovir disoproxil fumarateDRUG

Oral daily

Reduced doseStandard dose
LamivudineDRUG

Oral daily

Reduced doseStandard dose
EfavirenzDRUG

Oral daily

Reduced doseStandard dose

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • HIV antibody positive
  • Chinese nationality
  • Naïve to antiretroviral therapy
  • Willing to start antiretroviral therapy
  • Provision of written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Second Hospital of Nanjing

Nanjing, Jiangsu, 210003, China

Location

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 201508, China

Location

Yunnan AIDS care center

Kunming, Yunnan, 650041, China

Location

MeSH Terms

Conditions

HIV Infections

Interventions

TenofovirLamivudineefavirenz

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosides

Study Officials

  • Hongzhou Lu

    Shanghai Public Health Clinical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

October 14, 2016

First Posted

October 17, 2016

Study Start

March 5, 2018

Primary Completion

June 5, 2019

Study Completion

August 31, 2019

Last Updated

February 18, 2020

Record last verified: 2020-02

Locations

CN(3)