Optimization of Antiretroviral Therapy (OAT)

Shanghai Public Health Clinical Center

Status and phase: Completed; Phase 4

Conditions: HIV Infections

Treatments: Drug: Tenofovir disoproxil fumarate; Drug: Lamivudine; Drug: Efavirenz

Study type: Interventional

Funder types: Other

Identifiers

NCT02935075

2016-M-1

Details and patient eligibility

About

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.

Enrollment: 184 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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184 participants in 2 patient groups

Reduced dose

Experimental group

Description:

Tenofovir 200mg +lamivudine 300mg +efavirenz 400mg PO q.d.

Treatment:

Drug: Lamivudine

Drug: Tenofovir disoproxil fumarate

Drug: Efavirenz

Standard dose

Active Comparator group

Description:

Tenofovir 300mg +lamivudine 300mg +efavirenz 600mg PO q.d.

Treatment:

Drug: Lamivudine

Drug: Tenofovir disoproxil fumarate

Drug: Efavirenz