Optimization of Antiretroviral Therapy

Phase 4

Completed

• Conditions: HIV Infections
• Interventions: Drug: Tenofovir disoproxil fumarate; Drug: Lamivudine; Drug: Efavirenz

• Registration Number: NCT02935075
• Lead Sponsor: Shanghai Public Health Clinical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-14
• Study First Submitted QC: 2016-10-14
• Study First Posted: 2016-10-17
• Study Start: 2018-03-05
• Primary Completion: 2019-06-05
• Study Completion: 2019-08-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-16
• Last Update Posted: 2020-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reduced dose	Lamivudine	Tenofovir 200mg +lamivudine 300mg +efavirenz 400mg PO q.d.
Standard dose	Efavirenz	Tenofovir 300mg +lamivudine 300mg +efavirenz 600mg PO q.d.
Reduced dose	Tenofovir disoproxil fumarate	Tenofovir 200mg +lamivudine 300mg +efavirenz 400mg PO q.d.
Reduced dose	Efavirenz	Tenofovir 200mg +lamivudine 300mg +efavirenz 400mg PO q.d.
Standard dose	Tenofovir disoproxil fumarate	Tenofovir 300mg +lamivudine 300mg +efavirenz 600mg PO q.d.
Standard dose	Lamivudine	Tenofovir 300mg +lamivudine 300mg +efavirenz 600mg PO q.d.

Primary Outcome Measures

Name	Time	Method
Percentage of patients with HIV viral road < 50 copies/ml	48 weeks	calculate the percentage of patients who with HIV viral road \<50 copies/ml every month in two groups

Secondary Outcome Measures

Name	Time	Method
Cell Differentiation 4 (CD4) T cell counts	48 weeks

Trial Locations

Locations (3)

Yunnan AIDS care center; 🇨🇳 Kunming, Yunnan, China

The Second Hospital of Nanjing; 🇨🇳 Nanjing, Jiangsu, China

Shanghai Public Health Clinical Center; 🇨🇳 Shanghai, Shanghai, China