HIV-infection/Aids
Conditions
Keywords
FNC, HIV-infection, Aids
Brief summary
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.
Interventions
Sponsors
Henan Genuine Biotech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of subjects with plasma HIV-1 Ribonucleic acid (RNA) <50 copies/milliliter (c/mL) at Week 48 | 48 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of subjects with plasma HIV-1 Ribonucleic acid (RNA) <400 copies/milliliter (c/mL) at Week 24 ，Week 48 and Week 96； | Week 24 and Week 48 and Week 96, | Rate of participants with a HIV-1 RNA \< 50 copies per mL at Week 24，Week 48 and Week 96 |
| Change of CD4+ cell count from baseline at Week 48 and Week 96 | 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 |
| Time to achieve virologic failure（HIV-1 RNA<50 copies/ml） | Baseline and Week 96 | Time to HIV-1 RNA\<50 copies/ml from baseline |
| Rate of subjects with plasma HIV-1 Ribonucleic acid (RNA) <50 copies/milliliter (c/mL) at Week 24 and Week 96 | Week 24 and Week 96 | Rate of participants with a HIV-1 RNA \< 50 copies per mL at Week 24 and Week 96 |
| Diachronic change of CD4+T、 CD8+T cell count from baseline | Baseline and Week 96 | 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 |
| Safety outcome of subjects at Week 48 and Week 96。 | 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. |
| Diachronic change of logarithm (log) HIV-RNA reduction from baseline | Baseline and Week 96 | 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 |
Countries
China
Contacts
Primary ContactWu Hao
Backup ContactWan Yuanhao
Outcome results
None listed