Optimization of Antiretroviral Therapy (OAT)

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Tenofovir disoproxil fumarate; Drug: Lamivudine; Drug: Efavirenz

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210003
      • The Second Hospital of Nanjing
  • Shanghai
    • Shanghai, Shanghai, China, 201508
      • Shanghai Public Health Clinical Center
  • Yunnan
    • Kunming, Yunnan, China, 650041
      • Yunnan AIDS Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reduced dose; Tenofovir 200mg +lamivudine 300mg +efavirenz 400mg PO q.d.	Drug: Tenofovir disoproxil fumarate; Oral daily; Drug: Lamivudine; Oral daily; Drug: Efavirenz; Oral daily
Active Comparator: Standard dose; Tenofovir 300mg +lamivudine 300mg +efavirenz 600mg PO q.d.	Drug: Tenofovir disoproxil fumarate; Oral daily; Drug: Lamivudine; Oral daily; Drug: Efavirenz; Oral daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Cell Differentiation 4 (CD4) T cell counts	48 weeks

Other Outcome Measures

Outcome Measure	Time Frame
The incidence of adverse events	48 weeks

Collaborators and Investigators

• Sponsor: Shanghai Public Health Clinical Center
• Collaborators: Yunnan Provincial Infectious Disease Hospital; The Second Hospital of Nanjing Medical University
• Investigators: Principal Investigator: Hongzhou Lu, Shanghai Public Health Clinical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2018
• Primary Completion (Actual): June 5, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: October 14, 2016
• First Submitted That Met QC Criteria: October 14, 2016
• First Posted (Estimate): October 17, 2016

Study Record Updates

• Last Update Posted (Actual): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 16, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Tenofovir; Lamivudine; Efavirenz
• Other Study ID Numbers: 2016-M-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No