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

NCT ID: NCT04303598

Last Updated: 2020-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 720 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2022-08-01

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.

Conditions

HIV-infection/Aids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

FNC Treatment Group

FNC 3mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;3TC placebo 1 tablet;daily oral before bedtime

Group Type: EXPERIMENTAL

FNC

Intervention Type: DRUG

3mg, 1 tablet，QD

TDF

Intervention Type: DRUG

300mg, 1 tablet，QD

EFV

Intervention Type: DRUG

200mg, 1 tablet，QD

3TC placebo

Intervention Type: DRUG

1 tablet，QD

3TC control group

3TC 300mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;FNC placebo 1 tablet;daily oral before bedtime

Group Type: ACTIVE_COMPARATOR

3TC

Intervention Type: DRUG

300mg, 1 tablet，QD

TDF

Intervention Type: DRUG

300mg, 1 tablet，QD

EFV

Intervention Type: DRUG

200mg, 1 tablet，QD

FNC placebo

Intervention Type: DRUG

1 tablet，QD

Interventions

FNC

3mg, 1 tablet，QD

Intervention Type: DRUG

3TC

300mg, 1 tablet，QD

Intervention Type: DRUG

TDF

300mg, 1 tablet，QD

Intervention Type: DRUG

EFV

200mg, 1 tablet，QD

Intervention Type: DRUG

FNC placebo

1 tablet，QD

Intervention Type: DRUG

3TC placebo

1 tablet，QD

Intervention Type: DRUG

Other Intervention Names

Azvudine; Lamivudine; Tenofovir Fumarate; Efavirenz; Azvudine placebo; Lamivudine placebo

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Genuine Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing YouAn Hospital, Capital Medical University

Beijing, Beijing Municipality, 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

Countries

China

Central Contacts

Wu Hao

Role: CONTACT

whdoc@sina.com

+86 13601242523

Wan Yuanhao

Role: CONTACT

wanyuanhao@zsswkj.net

+86 13601242523

Facility Contacts

Wu Hao, MD

Role: primary

whdoc@sina.com

13501253203

Zhang Fujie

Role: primary

Chen Yaokai

Role: primary

Cai Weiping

Role: primary

Chengdu Xiaohong

Role: primary

Zhao Qingxia

Role: primary

Wang Min

Role: primary

He Shenghua

Role: primary

Ma Ping

Role: primary

Yu Jianhua

Role: primary

Other Identifiers

GQ-FNC-301

Identifier Type: -

Identifier Source: org_study_id