Phase III Clinical Study of Azvudine in Hiv-infected Treatment Naive Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: FNC Treatment Group FNC 3mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;3TC placebo 1 tablet;daily oral before bedtime |
Drug: FNC
3mg, 1 tablet，QD
Other Names:
Drug: TDF
300mg, 1 tablet，QD
Other Names:
Drug: EFV
200mg, 1 tablet，QD
Other Names:
Drug: 3TC placebo
1 tablet，QD
Other Names:
|
| Active Comparator: 3TC control group 3TC 300mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;FNC placebo 1 tablet;daily oral before bedtime |
Drug: 3TC
300mg, 1 tablet，QD
Other Names:
Drug: TDF
300mg, 1 tablet，QD
Other Names:
Drug: EFV
200mg, 1 tablet，QD
Other Names:
Drug: FNC placebo
1 tablet，QD
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- 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
- 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
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18-65 years old, regardless of gender;
-
Participant must have an positive HIV test;
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Have not received anti-HIV treatment;
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HIV-1 RNA≥1000 copies/ml and the investigators determined that the subjects were eligible for HAART therapy.
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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;
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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:
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History of allergy to any ingredient or excipient of the research drug or have a high sensitivity constitution;
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Patients with severe opportunistic infection or tumor;
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Clinically Hepatitis b surface antigen/hepatitis c antibody positive;
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Clinically Alanine transaminase and/or alanine transaminase ≥5× normal upper limit (ULN);
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Clinically Alanine aminotransferase ≥3×ULN and total bilirubin ≥2×ULN (direct bilirubin/total bilirubin > 35%);
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Glomerular filtration rate < 70ml/min/1.73m2 (calculated by ckd-epi Creatinine 2009 Equation), or Creatinine ≥ULN;
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Clinically significant diseases serious chronic diseases , metabolic diseases (such as diabetes), neurological and psychiatric diseases;
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History of pancreatitis;
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Women in pregnancy and breastfeeding;
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History of drug abuse, alcohol abuse and drug abuse;
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Participating in clinical trials of other drugs within the first three months of screening;
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Other factors considered inappropriate by the investigator to be included in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing YouAn Hospital, Capital Medical University | Beijing | Beijing | China | 100001 |
| 2 | Beijing DiTan Hospital, Capital Medical University | Beijing | Beijing | China | |
| 3 | Chongqing Public Health Medical Center | Chongqing | Chongqing | China | |
| 4 | Guangzhou Eighth People's Hospital | Guangzhou | Guangdong | China | |
| 5 | Wuhan Jinyintan Hospital | Wuhan | Hebei | China | |
| 6 | The Fouth Hospital of Harbin Medical University | Harbin | Heilongjiang | China | |
| 7 | The Sixth People's Hospital of Zhengzhou | Zhengzhou | Henan | China | |
| 8 | The First Hospital of Changsha | Changsha | Hunan | China | |
| 9 | The Second Hospital of Nanjing | Nanjing | Jiangsu | China | |
| 10 | The Public Health Clinical Center of Chengdu | Chengdu | Sichuan | China | |
| 11 | Tianjin Second People's Hospital | Tianjin | Tianjin | China | |
| 12 | Xixi Hospital of Hangzhou | Hangzhou | Zhejiang | China |
Sponsors and Collaborators
- HeNan Sincere Biotech Co., Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GQ-FNC-301