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

Henan Genuine Biotech Co., Ltd.720 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

720

Conditions

HIV-infection/Aids

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

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

...and 2 more locations

Outcomes

Primary Outcomes

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.

Time frame: 48 Weeks

Secondary Outcomes

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

Time frame: 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；

Rate of participants with a HIV-1 RNA \< 50 copies per mL at Week 24，Week 48 and Week 96

Time frame: Week 24 and Week 48 and Week 96,

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

Time frame: Week 48 and Week 96

Time to achieve virologic failure（HIV-1 RNA<50 copies/ml）

Time to HIV-1 RNA\<50 copies/ml from baseline

Time frame: Baseline and Week 96

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

Time frame: Baseline and Week 96

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

Time frame: Baseline and Week 96

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.

Time frame: Week 48 and Week 96

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

Overview

Conditions

Interventions

Eligibility

Locations (12)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts