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

HIV-infection/Aids Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04303598
• Other study ID #: GQ-FNC-301
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 1, 2020
• Est. completion date: August 1, 2022

Study information

• Verified date: March 2020
• Source: HeNan Sincere Biotech Co., Ltd
• Contact: Wu Hao
• Phone: +86 13601242523
• Email: whdoc[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 720
• Est. completion date: August 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections
• HIV-infection/Aids

Intervention

Drug:
• FNC
3mg, 1 tablet,QD
• 3TC
300mg, 1 tablet,QD
• TDF
300mg, 1 tablet,QD
• EFV
200mg, 1 tablet,QD
• FNC placebo
1 tablet,QD
• 3TC placebo
1 tablet,QD

Locations

Country	Name	City	State
China	Beijing DiTan Hospital, Capital Medical University	Beijing	Beijing
China	Beijing YouAn Hospital, Capital Medical University	Beijing	Beijing
China	The First Hospital of Changsha	Changsha	Hunan
China	The Public Health Clinical Center of Chengdu	Chengdu	Sichuan
China	Chongqing Public Health Medical Center	Chongqing	Chongqing
China	Guangzhou Eighth People's Hospital	Guangzhou	Guangdong
China	Xixi Hospital of Hangzhou	Hangzhou	Zhejiang
China	The Fouth Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Second Hospital of Nanjing	Nanjing	Jiangsu
China	Tianjin Second People`s Hospital	Tianjin	Tianjin
China	Wuhan Jinyintan Hospital	Wuhan	Hebei
China	The Sixth People's Hospital of Zhengzhou	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
HeNan Sincere Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of subjects with plasma HIV-1 Ribonucleic acid (RNA) <50 copies/milliliter (c/mL) at 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
Secondary	Rate of subjects with plasma HIV-1 Ribonucleic acid (RNA) <400 copies/milliliter (c/mL) at Week 24 ,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,
Secondary	Change of CD4+ cell count from baseline at 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
Secondary	Time to achieve virologic failure(HIV-1 RNA<50 copies/ml)	Time to HIV-1 RNA<50 copies/ml from baseline	Baseline and Week 96
Secondary	Diachronic change of logarithm (log) HIV-RNA reduction from baseline	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
Secondary	Diachronic change of CD4+T? CD8+T cell count from baseline	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
Secondary	Safety outcome of subjects at 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