Clinical trial NCT02935075: Optimization of Antiretroviral Therapy
Official title: Optimization of Antiretroviral Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Lead sponsor: Shanghai Public Health Clinical Center
Sponsor class: OTHER_GOV
Collaborators: name: Yunnan Provincial Infectious Disease Hospital
name: The Second Hospital of Nanjing Medical University
First posted: 2016-10-17
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients with HIV viral road < 50 copies/ml
timeFrame: 48 weeks
Secondary outcomes:
measure: Cell Differentiation 4 (CD4) T cell counts
timeFrame: 48 weeks
Other outcomes:
measure: The incidence of adverse events
timeFrame: 48 weeks
Locations:
city: Nanjing
country: China
facility: The Second Hospital of Nanjing
state: Jiangsu
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
city: Kunming
country: China
facility: Yunnan AIDS care center
state: Yunnan
Study officials:
affiliation: Shanghai Public Health Clinical Center
name: Hongzhou Lu
role: PRINCIPAL_INVESTIGATOR
References: