Dosing of Tenofovir and Efavirenz in Antiretroviral Therapy

• Sponsor: Shanghai Public Health Clinical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02945163
• Collaborator: The Second Hospital of Nanjing Medical University (Other), Yunnan Provincial Infectious Disease Hospital (Other)
• Enrollment: 184
• Locations: 3
• Arms: 2
• Actual Duration (Months): 17.9
• Patients Per Site: 61.3
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

Tenofovir+lamivudine+efavirenz is still the first line regimen of combination antiretroviral therapy in developing countries. 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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Tenofovir; Drug: Lamivudine; Drug: Efavirenz	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 184 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Optimization of HAART for Chinese--a RCT Study
• Actual Study Start Date: Mar 5, 2018
• Actual Primary Completion Date: Jun 5, 2019
• Actual Study Completion Date: Aug 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 Tenofovir 200mg + Lamivudine 300mg +Efavirenz 400mg PO Quaque die	Drug: Tenofovir; Tenofovir Disoproxil Fumarate; Drug: Lamivudine; Lamivudine; Drug: Efavirenz; Efavirenz
Active Comparator: Arm 2 Tenofovir 300mg + Lamivudine 300mg +Efavirenz 600mg PO Quaque die	Drug: Tenofovir; Tenofovir Disoproxil Fumarate; Drug: Lamivudine; Lamivudine; Drug: Efavirenz; Efavirenz

Outcome Measures

Primary Outcome Measures

1. Percentage of patients with HIV RNA<50 Copies/ml [48 weeks]

Secondary Outcome Measures

1. Adverse events [48 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Second Hospital of Nanjing	Nanjing	Jiangsu	China	210003
2	Shanghai Public Health Clinical Center	Shanghai	Shanghai	China	201508
3	Yunnan provincial infectious disease hosipital	Kunming	Yunnan	China	650041

Sponsors and Collaborators

• Shanghai Public Health Clinical Center
• The Second Hospital of Nanjing Medical University
• Yunnan Provincial Infectious Disease Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hongzhou Lu, Doctor, Shanghai Public Health Clinical Center
• ClinicalTrials.gov Identifier: NCT02945163
• Other Study ID Numbers: 2016-M-2
• First Posted: Oct 26, 2016
• Last Update Posted: Feb 18, 2020
• Last Verified: Feb 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: HIV Infections; Tenofovir; Lamivudine; Efavirenz

Study Results

No Results Posted as of Feb 18, 2020