Phase III Clinical Study of Azvudine in Hiv-infected Treatment Naive Patients
- Conditions
- HIV-infection/Aids
- Interventions
- Registration Number
- NCT04303598
- Lead Sponsor
- HeNan Sincere Biotech Co., Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 720
- 18-65 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FNC Treatment Group FNC FNC 3mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;3TC placebo 1 tablet;daily oral before bedtime FNC Treatment Group TDF FNC 3mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;3TC placebo 1 tablet;daily oral before bedtime FNC Treatment Group EFV FNC 3mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;3TC placebo 1 tablet;daily oral before bedtime FNC Treatment Group 3TC placebo FNC 3mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;3TC placebo 1 tablet;daily oral before bedtime 3TC control group TDF 3TC 300mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;FNC placebo 1 tablet;daily oral before bedtime 3TC control group EFV 3TC 300mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;FNC placebo 1 tablet;daily oral before bedtime 3TC control group FNC placebo 3TC 300mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;FNC placebo 1 tablet;daily oral before bedtime 3TC control group 3TC 3TC 300mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;FNC placebo 1 tablet;daily oral before bedtime
- Primary Outcome Measures
Name Time Method Rate of subjects with plasma HIV-1 Ribonucleic acid (RNA) <50 copies/milliliter (c/mL) at Week 48 48 Weeks 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.
- Secondary Outcome Measures
Name Time Method 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, Rate of participants with a HIV-1 RNA \< 50 copies per mL at Week 24，Week 48 and Week 96
Diachronic change of CD4+T、 CD8+T cell count from baseline Baseline and Week 96 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
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 participants with a HIV-1 RNA \< 50 copies per mL at Week 24 and Week 96
Change of CD4+ cell count from baseline at Week 48 and Week 96 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 to achieve virologic failure（HIV-1 RNA<50 copies/ml） Baseline and Week 96 Time to HIV-1 RNA\<50 copies/ml from baseline
Safety outcome of subjects at Week 48 and Week 96。 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.
Diachronic change of logarithm (log) HIV-RNA reduction from baseline Baseline and Week 96 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
Trial Locations
- Locations (12)
Beijing DiTan Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Guangzhou Eighth People's Hospital
🇨🇳Guangzhou, Guangdong, China
Chongqing Public Health Medical Center
🇨🇳Chongqing, Chongqing, China
The Second Hospital of Nanjing
🇨🇳Nanjing, Jiangsu, China
The Fouth Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
The First Hospital of Changsha
🇨🇳Changsha, Hunan, China
Tianjin Second People's Hospital
🇨🇳Tianjin, Tianjin, China
Xixi Hospital of Hangzhou
🇨🇳Hangzhou, Zhejiang, China
Wuhan Jinyintan Hospital
🇨🇳Wuhan, Hebei, China
The Sixth People's Hospital of Zhengzhou
🇨🇳Zhengzhou, Henan, China
Beijing YouAn Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
The Public Health Clinical Center of Chengdu
🇨🇳Chengdu, Sichuan, China