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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FNC Treatment Group | Experimental | FNC 3mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;3TC placebo 1 tablet;daily oral before bedtime |
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| 3TC control group | Active Comparator | 3TC 300mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;FNC placebo 1 tablet;daily oral before bedtime |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FNC | Drug | 3mg, 1 tablet,QD |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Rate of subjects with plasma HIV-1 Ribonucleic acid (RNA) <400 copies/milliliter (c/mL) at Week 24 ,Week 48 and Week 96; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wu Hao | Contact | +86 13601242523 | whdoc@sina.com | |
| Wan Yuanhao | Contact | +86 13601242523 | wanyuanhao@zsswkj.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing YouAn Hospital, Capital Medical University | Beijing | Beijing Municipality | 100001 | China |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C540945 | azvudine |
| D019259 | Lamivudine |
| C098320 | efavirenz |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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The experiment was conducted under a randomized method, each center disputed into the group via competition. Treatment assignment was carried out in accordance with a central randomization schedule generated with SAS (version 9.4). Randomization was done by a computer-generated system (IWRS). The randomization table (1st blind code) and second blind code were sealed and stored in triplicate offices of the sponsor, investigator and the independent statistician.
| 3TC | Drug | 300mg, 1 tablet,QD |
|
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| TDF | Drug | 300mg, 1 tablet,QD |
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| EFV | Drug | 200mg, 1 tablet,QD |
|
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| FNC placebo | Drug | 1 tablet,QD |
|
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| 3TC placebo | Drug | 1 tablet,QD |
|
|
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, |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Beijing DiTan Hospital, Capital Medical University | Beijing | Beijing Municipality | China |
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| Chongqing Public Health Medical Center | Chongqing | Chongqing Municipality | China |
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| Guangzhou Eighth People's Hospital | Guangzhou | Guangdong | China |
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| Wuhan Jinyintan Hospital | Wuhan | Hebei | China |
| The Fouth Hospital of Harbin Medical University | Harbin | Heilongjiang | China |
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| 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 |
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| Tianjin Second People's Hospital | Tianjin | Tianjin Municipality | China |
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| Xixi Hospital of Hangzhou | Hangzhou | Zhejiang | China |
|
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |