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A Drug Safety and Dose-exploratory Clinical Study of Azvudine Tablets in Patients Who Have Not Received Anti-HIV Treatment

NCT04109183 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2019-09-30

No results posted yet for this study

Summary

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 .

Conditions

  • AIDS

Interventions

DRUG

The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.

The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.

Sponsors & Collaborators

  • Beijing YouAn Hospital

    collaborator OTHER

  • Peking Union Medical College Hospital

    collaborator OTHER

  • Beijing Ditan Hospital

    collaborator OTHER

  • Guangzhou 8th People's Hospital

    collaborator OTHER

  • The Sixth People's Hospital of Zhengzhou

    collaborator OTHER

  • Henan Genuine Biotech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-10
Primary Completion
2019-01-28
Completion
2019-03-06

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04109183 on ClinicalTrials.gov