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

NCT04109183 | Completed Phase 2

• 1 other identifier: GQ-FNC-201
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HIV/AIDS

Outcome Measures

Primary Outcomes (2)

• Evaluation of azivudine tablet (FNC) combined with reverse transcriptase inhibitor therapy without anti-hiv treatment.

  Number of subjects with HIV viral load \< 50copies/ml after treatment

  At 48 weeks

• Preliminary evaluation of the efficacy of azivudine tablets (FNC) combined with reverse transcriptase inhibitors in the treatment of patients who have not received anti-hiv treatment.

  Number of subjects with HIV viral load \< 50copies/ml after treatment

  At 48 weeks

Secondary Outcomes (1)

• To explore the effective dose of azivudine tablet (FNC) in clinic

  At 48 weeks

Study Arms (4)

Active Comparator: FNC 2 mg+ TDF+EFV

EXPERIMENTAL

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

Active Comparator: FNC 3 mg+ TDF+EFV

EXPERIMENTAL

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

Active Comparator: FNC 4 mg+ TDF+EFV

EXPERIMENTAL

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

Postive Comparator: 3TC+ TDF+EFV

EXPERIMENTAL

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

Interventions

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

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

Active Comparator: FNC 2 mg+ TDF+EFV; Active Comparator: FNC 3 mg+ TDF+EFV; Active Comparator: FNC 4 mg+ TDF+EFV; Postive Comparator: 3TC+ TDF+EFV

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old, regardless of gender; 2.Confirmed HIV positive with a report; 3.Have not received anti-hiv antiviral treatment; 4.HIV viral load ≥1000 copies/mL; 5.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; 6.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.

You may not qualify if:

• Patients who have received anti-HIV treatment;
• Suffering from a serious opportunistic infection or opportunistic tumor;
• Abnormal blood routine examination (white blood cells \<3 × 109 / L, hemoglobin \<90g / L, neutrophils \<1.5 × 109 / L, platelets \<75 × 109 / L);
• Have a definite liver disease (hepatitis B surface antigen/HCV antibody positive), or abnormal liver function test (alanine aminotransferase and/or aspartate aminotransferase exceeds the upper limit of normal value by 3 times, or total bilirubin exceeds the upper limit of normal value 2 times);
• Renal insufficiency (glomerular filtration rate \<70ml/min, or creatinine above the upper limit of normal);
• Now suffering from more serious chronic diseases, metabolic diseases (such as diabetes), neurological and psychiatric diseases;
• Has suffered from pancreatitis;
• Women during pregnancy and lactation;
• allergic constitution or known to be allergic to the pharmaceutical ingredients and the basic drugs prescribed in this program;
• Suspect or determine the history of alcohol and drug abuse;
• Participated in other drug clinical trials (excluding Chinese medicine) within the first three months of screening;
• Other factors that are not suitable for entering the trial.

Sponsors & Collaborators

• Henan Genuine Biotech Co., Ltd.: lead
• Beijing YouAn Hospital: collaborator
• Peking Union Medical College Hospital: collaborator
• Beijing Ditan Hospital: collaborator
• Guangzhou 8th People's Hospital: collaborator
• The Sixth People's Hospital of Zhengzhou: collaborator

Study Sites (1)

Beijing YouAn Hospital, Capital Medical University.

Beijing, Beijing Municipality, 10000, China

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: This experiment used a block randomization method, and each research center competed for inclusion. The SAS software (9.3 or above) was used to generate a random table and the corresponding treatment group for the random table. The clinical trial electronic central stochastic system (DAS for IWRS) was used to assign random numbers.Blind bottom sealed preservation, respectively sealed by the sponsor and clinical research unit.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: a multicenter, randomized, double-blind, double-simulation, positive control trial.

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 30, 2019
• Study Start: October 10, 2017
• Primary Completion: January 28, 2019
• Study Completion: March 6, 2019
• Last Updated: September 30, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)