Phase III Clinical Study of Azvudine in Hiv-infected Treatment Naive Patients

HeNan Sincere Biotech

Status and phase: Unknown; Phase 3

Conditions: HIV-infection/Aids

Treatments: Drug: FNC; Drug: 3TC placebo; Drug: 3TC; Drug: FNC placebo; Drug: TDF; Drug: EFV

Study type: Interventional

Funder types: Industry

Identifiers

NCT04303598

GQ-FNC-301

Details and patient eligibility

About

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.

Enrollment: 720 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18-65 years old, regardless of gender;
2. Participant must have an positive HIV test;
3. Have not received anti-HIV treatment;
4. HIV-1 RNA≥1000 copies/ml and the investigators determined that the subjects were eligible for HAART therapy.
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.

Exclusion criteria

1. History of allergy to any ingredient or excipient of the research drug or have a high sensitivity constitution;
2. Patients with severe opportunistic infection or tumor;
3. Clinically Hepatitis b surface antigen/hepatitis c antibody positive;
4. Clinically Alanine transaminase and/or alanine transaminase ≥5× normal upper limit (ULN);
5. Clinically Alanine aminotransferase ≥3×ULN and total bilirubin ≥2×ULN (direct bilirubin/total bilirubin > 35%);
6. Glomerular filtration rate < 70ml/min/1.73m2 (calculated by ckd-epi Creatinine 2009 Equation), or Creatinine ≥ULN;
7. Clinically significant diseases serious chronic diseases , metabolic diseases (such as diabetes), neurological and psychiatric diseases;
8. History of pancreatitis;
9. Women in pregnancy and breastfeeding;
10. History of drug abuse, alcohol abuse and drug abuse;
11. Participating in clinical trials of other drugs within the first three months of screening;
12. Other factors considered inappropriate by the investigator to be included in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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720 participants in 2 patient groups

FNC Treatment Group

Experimental group

Description:

FNC 3mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;3TC placebo 1 tablet;daily oral before bedtime

Treatment:

Drug: EFV

Drug: TDF

Drug: 3TC placebo

Drug: FNC

3TC control group

Active Comparator group

Description:

3TC 300mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;FNC placebo 1 tablet;daily oral before bedtime

Treatment:

Drug: EFV

Drug: TDF

Drug: FNC placebo

Drug: 3TC