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NCT04109183: FNC
A Drug Safety and Dose-exploratory Clinical Study of Azvudine Tablets in Patients Who Have Not Received Anti-HIV Treatment
Phase 2 trial testing The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF. in AIDS in 172 participants. Completed in 6 March 2019.
28 January 2019
Quick facts
| Lead sponsor | Henan Genuine Biotech Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 172 |
| Start date | 10 October 2017 |
| Primary completion | 28 January 2019 |
| Estimated completion | 6 March 2019 |
| Sites | 1 location across China |
Drugs / interventions tested
- The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.
Conditions studied
- AIDS — all drugs for AIDS →
Sponsor
Henan Genuine Biotech Co., Ltd. — full company profile →
Who can join
Adults 18 to 65, any sex, with AIDS. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objective of this trial was to evaluate the safety and preliminary evaluation of Azvudine tablets (FNC) in combination with reverse transcriptase inhibitors therapy in treatment-naive patients with HIV infection.; the secondary objective is to explore the effective dose of clinical use of Azvudine (FNC) tablets .
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04109183
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Henan Genuine Biotech Co., Ltd. trials
Trials by the same sponsor.
- NCT07362940 — A Phase Ⅰ/Ⅱa Clinical Study of GEN-725 in Combination With Dositinib · Phase 1, PHASE2 · recruiting
- NCT07001436 — A Pharmacokinetics and Safety Study of Azvudine Tablets in Subjects With Mild-To-Moderate GFR Decline in Renal Insuffici · Phase 1 · recruiting
- NCT07229898 — A Phase Ⅰ Clinical Study of GEN-725 Tablets in Patients With Advanced Solid Tumors · Phase 1 · recruiting
- NCT07002281 — [14C] Mass Balance Clinical Trial of Azvudine in Healthy Male Subjects · Phase 1 · completed
- NCT06991634 — A Study to Evaluate the Pharmacokinetics and Safety of Azvudine Tablets in Healthy Adult Subjects and Healthy Elderly Su · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04109183 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Henan Genuine Biotech Co., Ltd.
- Last refreshed: 30 September 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04109183.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing