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Completed

NCT Number: NCT02935075

Optimization of Antiretroviral Therapy

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Second Hospital of Nanjing, Nanjing, Jiangsu, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Tenofovir disoproxil fumarate

Drug

Oral daily

Lamivudine

Drug

Oral daily

Efavirenz

Drug

Oral daily

Primary outcomes

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

    Time frame: 48 weeks

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

Secondary outcomes

  1. Cell Differentiation 4 (CD4) T cell counts

    Time frame: 48 weeks

Other outcomes

  1. The incidence of adverse events

    Time frame: 48 weeks

Sponsors and collaborators

Lead sponsor

Shanghai Public Health Clinical Center

Other Gov

Collaborators

  • The Second Hospital of Nanjing Medical University
  • Yunnan Provincial Infectious Disease Hospital

Registry information

Acronym: OAT

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 17, 2016
Registry last updated
Feb 18, 2020

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.

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