Clinical trial NCT04303598: Phase III Clinical Study of Azvudine in Hiv-infected Treatment Naive Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: HIV-infection/Aids
Keywords: FNC
HIV-infection
Aids
Lead sponsor: Henan Genuine Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-03-11
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of subjects with plasma HIV-1 Ribonucleic acid (RNA) <50 copies/milliliter (c/mL) at Week 48
timeFrame: 48 Weeks
Secondary outcomes:
measure: Rate of subjects with plasma HIV-1 Ribonucleic acid (RNA) <50 copies/milliliter (c/mL) at Week 24 and Week 96
timeFrame: Week 24 and Week 96
measure: Rate of subjects with plasma HIV-1 Ribonucleic acid (RNA) <400 copies/milliliter (c/mL) at Week 24 ，Week 48 and Week 96；
timeFrame: Week 24 and Week 48 and Week 96,
measure: Change of CD4+ cell count from baseline at Week 48 and Week 96
timeFrame: Week 48 and Week 96
measure: Time to achieve virologic failure（HIV-1 RNA<50 copies/ml）
timeFrame: Baseline and Week 96
measure: Diachronic change of logarithm (log) HIV-RNA reduction from baseline
timeFrame: Baseline and Week 96
measure: Diachronic change of CD4+T、 CD8+T cell count from baseline
timeFrame: Baseline and Week 96
measure: Safety outcome of subjects at Week 48 and Week 96。
timeFrame: Week 48 and Week 96
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing YouAn Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing DiTan Hospital, Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: Chongqing Public Health Medical Center
state: Chongqing
city: Guangzhou
country: China
facility: Guangzhou Eighth People's Hospital
state: Guangdong
city: Wuhan
country: China
facility: Wuhan Jinyintan Hospital
state: Hebei
city: Harbin
country: China
facility: The Fouth Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: The Sixth People's Hospital of Zhengzhou
state: Henan
city: Changsha
country: China
facility: The First Hospital of Changsha
state: Hunan
city: Nanjing
country: China
facility: The Second Hospital of Nanjing
state: Jiangsu
city: Chengdu
country: China
facility: The Public Health Clinical Center of Chengdu
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Second People's Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Xixi Hospital of Hangzhou
state: Zhejiang
Study officials:
References: