Optimization of Antiretroviral Therapy

HIV Infections Clinical Trial

— OAT  

Official title:

Optimization of Antiretroviral Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02935075
• Other study ID #: 2016-M-1
• Status: Completed
• Phase: Phase 4
• Start date: March 5, 2018
• Est. completion date: August 31, 2019

Study information

• Verified date: February 2020
• Source: Shanghai Public Health Clinical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: August 31, 2019
• Est. primary completion date: June 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Tenofovir disoproxil fumarate
Oral daily
• Lamivudine
Oral daily
• Efavirenz
Oral daily

Locations

Country	Name	City	State
China	Yunnan AIDS care center	Kunming	Yunnan
China	The Second Hospital of Nanjing	Nanjing	Jiangsu
China	Shanghai Public Health Clinical Center	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai Public Health Clinical Center	The Second Hospital of Nanjing Medical University, Yunnan Provincial Infectious Disease Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The incidence of adverse events		48 weeks
Primary	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	Cell Differentiation 4 (CD4) T cell counts		48 weeks