Skip to main content
OpenTrials
Completed

NCT Number: NCT02632474

ART Drug Dosage Adjustment in HIV-infected Population

The purpose of this study is to determine efficacy of the combination of low dose of Tenofovir, Efavirenz and Lamivudine in treating HIV-infection.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 201508, China

About this study

The feedback system control (FSC) technique has been developed to rapidly identify optimal combinations for therapeutic purposes. Low dose of TDF+3TC+EFV combination has been test in vitro study by FSC which showed high efficacy and now the investigators apply it to human to further optimize the ART combination.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV antibody positive
  • HIV RNA below 10*E5 copies/ml
  • CD4 T cell count above 200 cells/ml
  • Provision of written informed consent

Exclusion criteria

  • HIV genotyping resistant to investigating drug
  • Pregnant, breastfeeding, or lactating
  • 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 <7.0 grams/decilitre (g/dL)
  • Neutrophil count <500/mm3
  • Platelet count <50,000/mm3
  • Aspartate aminotransferase or Alanine transaminase >5 times Upper Limit of Normal (ULN)
  • Subjects with an estimated creatinine clearance of <50 mL/minute

Treatment and study plan

Tenofovir(TDF)+Lamivudine(3TC)+Efavirenz(EFV)

Drug

The first 2 weeks, TDF (300 mg) + 3-TC (300 mg) + EFV (400 mg); week 3, TDF (200 mg) + 3-TC (300 mg) + EFV (400 mg ); week 4, TDF (150 mg) + 3-TC (300 mg) + EFV (400 mg).From week5, if the HIV viral load decreased as expected or no rebound, use TDF (200 mg) + 3-TC (300 mg) + EFV (400 mg) until study complete; if the viral load increases, switch to the standard treatment regimen: TDF (300 mg) + 3-TC (300 mg) + EFV (600 mg).

Primary outcomes

  1. HIV viral load

    Time frame: 48 weeks

Secondary outcomes

  1. CD4 Count

    Time frame: 48 weeks

Other outcomes

  1. Drug Plasma Concentration

    Time frame: Day 7,14,21,28

Sponsors and collaborators

Lead sponsor

Shanghai Public Health Clinical Center

Other Gov

Registry information

Official study title

ART Drug Dosage Adjustment Using FSCII in Chinese HIV-infected Population

Important dates

Study start
2015
Primary completion
2016
First posted
Dec 16, 2015
Registry last updated
Jan 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.