Phase III Clinical Study of Azvudine in Hiv-infected Treatment Naive Patients

March 6, 2020 updated by: HeNan Sincere Biotech Co., Ltd

A Randomized, Double-blind, Double-simulated, Active-controlled,Phase III Clinical Study Evaluating the Efficacy and Safety of Azvudine Combined With Tenofovir Fumarate and Efavirenz in Hiv-infected Treatment Naive Patients

Azvudine,(FNC), new nuclear nucleoside reverse transcriptase inhibitors, FNC make itself a better candidate to be co-formulated in other anti-HIV therapies, thus to improve patient's compliance, approved by state drug administration (NMPA) for clinical research. FNC has completed its phase I、II clinical studies with desirable results.This is a multi-center, randomized, double-blind,double-placebo,active-control clinical trial. Subjects in experimental arm receives FNC+TDF+EFV+3TC placebo, while the subjected in active control arm receives 3TC+TDF+EFV+FNC placebo. The background drugs in both arms are conducted in open-label design while FNC and 3TC are conducted in double-blinded design.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

720

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Beijing
      • Beijing, Beijing, China
        • Beijing Ditan Hospital, Capital Medical University
        • Contact:
          • Zhang Fujie
      • Beijing, Beijing, China, 100001
        • Beijing Youan Hospital, Capital Medical University
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China
        • Chongqing Public Health Medical Center
        • Contact:
          • Chen Yaokai
    • Guangdong
      • Guangzhou, Guangdong, China
        • Guangzhou Eighth People's Hospital
        • Contact:
          • Cai Weiping
    • Hebei
      • Wuhan, Hebei, China
        • Wuhan Jinyintan Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • The Fouth Hospital of Harbin Medical University
        • Contact:
          • Chengdu Xiaohong
    • Henan
      • Zhengzhou, Henan, China
        • The Sixth People's Hospital of Zhengzhou
        • Contact:
          • Zhao Qingxia
    • Hunan
      • Changsha, Hunan, China
        • The First Hospital of Changsha
        • Contact:
          • Wang Min
    • Jiangsu
      • Nanjing, Jiangsu, China
        • The Second Hospital of Nanjing
    • Sichuan
      • Chengdu, Sichuan, China
        • The Public Health Clinical Center Of Chengdu
        • Contact:
          • He Shenghua
    • Tianjin
      • Tianjin, Tianjin, China
        • Tianjin Second People's Hospital
        • Contact:
          • Ma Ping
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Xixi hospital of Hangzhou
        • Contact:
          • Yu Jianhua

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18-65 years old, regardless of gender;
  2. Participant must have an positive HIV test;
  3. Have not received anti-HIV treatment;
  4. HIV-1 RNA≥1000 copies/ml and the investigators determined that the subjects were eligible for HAART therapy.
  5. Who have no recent family planning and agree to take effective non-drug contraceptive measures during the trial period and within 3 months after the end of administration;
  6. The subjects could fully understand the purpose, nature, method and possible adverse reactions of the test, and voluntarily participate in and sign the informed consent.

Exclusion Criteria:

  1. History of allergy to any ingredient or excipient of the research drug or have a high sensitivity constitution;
  2. Patients with severe opportunistic infection or tumor;
  3. Clinically Hepatitis b surface antigen/hepatitis c antibody positive;
  4. Clinically Alanine transaminase and/or alanine transaminase ≥5× normal upper limit (ULN);
  5. Clinically Alanine aminotransferase ≥3×ULN and total bilirubin ≥2×ULN (direct bilirubin/total bilirubin > 35%);
  6. Glomerular filtration rate < 70ml/min/1.73m2 (calculated by ckd-epi Creatinine 2009 Equation), or Creatinine ≥ULN;
  7. Clinically significant diseases serious chronic diseases , metabolic diseases (such as diabetes), neurological and psychiatric diseases;
  8. History of pancreatitis;
  9. Women in pregnancy and breastfeeding;
  10. History of drug abuse, alcohol abuse and drug abuse;
  11. Participating in clinical trials of other drugs within the first three months of screening;
  12. Other factors considered inappropriate by the investigator to be included in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FNC Treatment Group
FNC 3mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;3TC placebo 1 tablet;daily oral before bedtime
3mg, 1 tablet,QD
Other Names:
  • Azvudine
300mg, 1 tablet,QD
Other Names:
  • Tenofovir Fumarate
200mg, 1 tablet,QD
Other Names:
  • Efavirenz
1 tablet,QD
Other Names:
  • Lamivudine placebo
Active Comparator: 3TC control group
3TC 300mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;FNC placebo 1 tablet;daily oral before bedtime
300mg, 1 tablet,QD
Other Names:
  • Tenofovir Fumarate
200mg, 1 tablet,QD
Other Names:
  • Efavirenz
300mg, 1 tablet,QD
Other Names:
  • Lamivudine
1 tablet,QD
Other Names:
  • Azvudine placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of subjects with plasma HIV-1 Ribonucleic acid (RNA) <50 copies/milliliter (c/mL) at Week 48
Time Frame: 48 Weeks
Rate of participants with a HIV-1 RNA < 50 copies per mL .If HIV RNA level is < 50 copies per mL at Week 48, it is considered as virologic success as per the snapshot approach.
48 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of subjects with plasma HIV-1 Ribonucleic acid (RNA) <50 copies/milliliter (c/mL) at Week 24 and Week 96
Time Frame: Week 24 and Week 96
Rate of participants with a HIV-1 RNA < 50 copies per mL at Week 24 and Week 96
Week 24 and Week 96
Rate of subjects with plasma HIV-1 Ribonucleic acid (RNA) <400 copies/milliliter (c/mL) at Week 24 ,Week 48 and Week 96;
Time Frame: Week 24 and Week 48 and Week 96,
Rate of participants with a HIV-1 RNA < 50 copies per mL at Week 24,Week 48 and Week 96
Week 24 and Week 48 and Week 96,
Change of CD4+ cell count from baseline at Week 48 and Week 96
Time Frame: Week 48 and Week 96
The immunologic change was determined by changes in Cluster of CD4+ cell count. Change from baseline in CD4+ cell count at Weeks 48 and 96 were assessed
Week 48 and Week 96
Time to achieve virologic failure(HIV-1 RNA<50 copies/ml)
Time Frame: Baseline and Week 96
Time to HIV-1 RNA<50 copies/ml from baseline
Baseline and Week 96
Diachronic change of logarithm (log) HIV-RNA reduction from baseline
Time Frame: Baseline and Week 96
The Diachronic change of logarithm (log) HIV-RNA change was determined by changes in Cluster of logarithm (log) HIV-RNA count. Change from baseline in logarithm (log) HIV-RNA at Weeks 96 were assessed
Baseline and Week 96
Diachronic change of CD4+T、 CD8+T cell count from baseline
Time Frame: Baseline and Week 96
The immunologic change was determined by changes in Cluster of CD4+ cell count. Change from baseline in CD4+ cell count to Weeks 96 were assessed
Baseline and Week 96
Safety outcome of subjects at Week 48 and Week 96。
Time Frame: Week 48 and Week 96
Rate of participants discontinuing therapy due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Week 48 and Week 96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2020

Primary Completion (Anticipated)

May 1, 2022

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

March 4, 2020

First Submitted That Met QC Criteria

March 6, 2020

First Posted (Actual)

March 11, 2020

Study Record Updates

Last Update Posted (Actual)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 6, 2020

Last Verified

March 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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