Efficacy of Efavirenz 400mg vs. 600mg Combined With Lamivudine and Tenofovir in Treatment Naive HIV Infection

NCT04463784 | Unknown DMC

• 1 other identifier: CACT 1809
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The present study will be a randomized controlled study in which 500 treatment-naive HIV patients will be randomized 1:1 to Efaviren 400mg v.s. 600mg combined with lamivudine and tenofovir. The whole cohort will be followed for two years. Efficacy and safety of each regimen will be evaluated throughout the study.

Conditions

HIV/AIDS; Mental Impairment

Outcome Measures

Primary Outcomes (10)

• Change from Baseline Virological measurements at 12 weeks

  Plasma viral load

  12 weeks

• Change from Baseline Virological measurements at 24 weeks

  Plasma viral load

  24 weeks

• Change from Baseline Virological measurements at 48 weeks

  Plasma viral load

  48 weeks

• Change from Baseline Virological measurements at 72 weeks

  Plasma viral load

  72 weeks

• Change from Baseline Virological measurements at 96 weeks

  Plasma viral load

  96 weeks

• Change from Baseline Immunological measurements at 12 weeks

  CD4 T cell count

  12 weeks

• Change from Baseline Immunological measurements at 24 weeks

  CD4 T cell count

  24 weeks

• Change from Baseline Immunological measurements at 48 weeks

  CD4 T cell count

  48 weeks

• Change from Baseline Immunological measurements at 72 weeks

  CD4 T cell count

  72 weeks

• Change from Baseline Immunological measurements at 96 weeks

  CD4 T cell count

  96 weeks

Secondary Outcomes (3)

• Adverse effects measured by Dizziness Handicap Inventory

  0, 12, 24, 48, 72, 96 weeks

• Adverse effects measured by Hamilton Depression Scale-24

  0, 12, 24, 48, 72, 96 weeks

• Adverse effects measured by Pittsburgh Sleep Quality Index

  0, 12, 24, 48, 72, 96 weeks

Study Arms (2)

Efavirenz 400MG Oral Tablet

EXPERIMENTAL

Recruited treatment-naive HIV infected patients will be given Lamivudin 300mg per day, tenofovir 300mg per day and efavirenz 400mg per day as antiretroviral treatment.

Drug: Efavirenz 400Mg Oral Tablet

Efavirenz 600MG Oral Tablet

ACTIVE COMPARATOR

Recruited treatment-naive HIV infected patients will be given Lamivudin 300mg per day, tenofovir 300mg per day and efavirenz 600mg per day, per standard dose.

Drug: Efavirenz 600Mg Oral Tablet

Interventions

Efavirenz 400Mg Oral Tablet DRUG

The experimental arm will receive 400mg efavirenz per randomization with other two antiretroviral medication (tenofovir and lamivudine).

Efavirenz 400MG Oral Tablet

Efavirenz 600Mg Oral Tablet DRUG

The active comparator arm will receive 600mg efavirenz per randomization with other two antiretroviral medication (tenofovir and lamivudine).

Efavirenz 600MG Oral Tablet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Willingness and availability to engage in study activities for the duration of the study
• Age between 18-65
• Documented HIV-1 infection (confirmed by Western blot)
• Received no prior antiretroviral therapy

You may not qualify if:

• Pregnancy or breastfeeding or anticipated pregnancy in two years
• History of AIDS-defining illness
• Hemoglobin \< 9g/dl；or peripheral white blood cell counts \< 2000/μl；or neutrophil counts \< 1000 /μl；or platelet count \< 75,000/μl；
• Liver disease (transaminase and alkaline phosphatase levels more than three times the upper limit of the normal range (ULN), bilirubin level more than 2.5 times the ULN)
• Chronic kidney disease (serum creatinine level more than 1.5 times the ULN)
• Patients with a history of injection drug usage
• Patients with a history of mental disorders

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (1)

• Tongtong Y, Shenghua H, Yin W, Lin C, Huanxia L, Chunrong L, Ruifeng Z, Xiaojing Y, Yuan Y, Yuanhong H, Ke Y. Effectiveness and Safety of Dolutegravir Versus Efavirenz-Based Antiviral Regimen in People Living With HIV-1 in Sichuan Province of China: A Real-World Study. J Acquir Immune Defic Syndr. 2022 Oct 1;91(S1):S1-S7. doi: 10.1097/QAI.0000000000003041.

  PMID: 36094508 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

efavirenz; Tablets

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Taisheng Li, PhD, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Department of Infectious Diseases

Study Record Dates

• First Submitted: July 15, 2018
• First Posted: July 9, 2020
• Study Start: April 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: August 1, 2021
• Last Updated: July 9, 2020

Record last verified: 2020-07

Locations

CN (1)