Phase III Clinical Study of Azvudine in Hiv-infected Treatment Naive Patients
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
1 other identifier
interventional
720
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2020
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2020
CompletedFirst Posted
Study publicly available on registry
March 11, 2020
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedMarch 11, 2020
March 1, 2020
2.1 years
March 4, 2020
March 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of subjects with plasma HIV-1 Ribonucleic acid (RNA) <50 copies/milliliter (c/mL) at Week 48
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 Outcomes (7)
Rate of subjects with plasma HIV-1 Ribonucleic acid (RNA) <50 copies/milliliter (c/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；
Week 24 and Week 48 and Week 96,
Change of CD4+ cell count from baseline at Week 48 and Week 96
Week 48 and Week 96
Time to achieve virologic failure（HIV-1 RNA<50 copies/ml）
Baseline and Week 96
Diachronic change of logarithm (log) HIV-RNA reduction from baseline
Baseline and Week 96
- +2 more secondary outcomes
Study Arms (2)
FNC Treatment Group
EXPERIMENTALFNC 3mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;3TC placebo 1 tablet;daily oral before bedtime
3TC control group
ACTIVE COMPARATOR3TC 300mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;FNC placebo 1 tablet;daily oral before bedtime
Interventions
Eligibility Criteria
You may qualify if:
- years old, regardless of gender;
- Participant must have an positive HIV test;
- Have not received anti-HIV treatment;
- HIV-1 RNA≥1000 copies/ml and the investigators determined that the subjects were eligible for HAART therapy.
- 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;
- 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.
You may not qualify if:
- History of allergy to any ingredient or excipient of the research drug or have a high sensitivity constitution;
- Patients with severe opportunistic infection or tumor;
- Clinically Hepatitis b surface antigen/hepatitis c antibody positive;
- Clinically Alanine transaminase and/or alanine transaminase ≥5× normal upper limit (ULN);
- Clinically Alanine aminotransferase ≥3×ULN and total bilirubin ≥2×ULN (direct bilirubin/total bilirubin \> 35%);
- Glomerular filtration rate \< 70ml/min/1.73m2 (calculated by ckd-epi Creatinine 2009 Equation), or Creatinine ≥ULN;
- Clinically significant diseases serious chronic diseases , metabolic diseases (such as diabetes), neurological and psychiatric diseases;
- History of pancreatitis;
- Women in pregnancy and breastfeeding;
- History of drug abuse, alcohol abuse and drug abuse;
- Participating in clinical trials of other drugs within the first three months of screening;
- Other factors considered inappropriate by the investigator to be included in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Beijing YouAn Hospital, Capital Medical University
Beijing, Beijing Municipality, 100001, China
Beijing DiTan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Chongqing Public Health Medical Center
Chongqing, Chongqing Municipality, China
Guangzhou Eighth People's Hospital
Guangzhou, Guangdong, China
Wuhan Jinyintan Hospital
Wuhan, Hebei, China
The Fouth Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The Sixth People's Hospital of Zhengzhou
Zhengzhou, Henan, China
The First Hospital of Changsha
Changsha, Hunan, China
The Second Hospital of Nanjing
Nanjing, Jiangsu, China
The Public Health Clinical Center of Chengdu
Chengdu, Sichuan, China
Tianjin Second People's Hospital
Tianjin, Tianjin Municipality, China
Xixi Hospital of Hangzhou
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- The experiment was conducted under a randomized method, each center disputed into the group via competition. Treatment assignment was carried out in accordance with a central randomization schedule generated with SAS (version 9.4). Randomization was done by a computer-generated system (IWRS). The randomization table (1st blind code) and second blind code were sealed and stored in triplicate offices of the sponsor, investigator and the independent statistician.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2020
First Posted
March 11, 2020
Study Start
April 1, 2020
Primary Completion
May 1, 2022
Study Completion
August 1, 2022
Last Updated
March 11, 2020
Record last verified: 2020-03