Efficacy and Safety of Tenofovir Plus Lamivudine Plus Efavirenz Regimen as First-line Antiretroviral Therapy
Efficacy and Safety of Tenofovir Disoproxil Fumarate Plus Lamivudine Plus Efavirenz Regimen as First-line Antiretroviral Therapy for ART-naive Chinese Patients With HIV-1 Infection
Studieoversikt
Detaljert beskrivelse
This study is a prospective, open-label, multi-centered clinical trial to assess the virologic suppression and immune recovery rates as well as tolerability of the regimen 3TC+TDF+EFV in ARV-naive Chinese population.
500 eligible participants will be recruited to take the regimen If the patient fails to tolerate EFV, it can be substituted by NVP when CD4 < 250/μL, and by LPV/r when CD4 > 250/uL. If the patient fails to tolerate TDF, AZT will be an alternative, except when Hb < 90/L or neutrophil count < 0.75×109/L. The participants will be followed up by months 0.5, 1, 2 ,3 and every 3 months subsequently for 2 years.
The efficacy of the regimen will be evaluated by comparison between different points along the time line and previous regimens. The safety of the regimen will be assessed by monitoring kidney function, bone density, cardiovascular profile, lipid profile, liver function etc as well as other adverse events.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Beijing
-
Beijing, Beijing, Kina, 100730
- Peking Union Medical College Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- age between 18-65 years of either gender
- HIV-1 antibody seropositive detected by ELISA and confirmed by western blot
- CD4 cell count < 500/ul
- Signed informed consent, with no condition that precludes follow-up for 2 years
- No plan to move out of the area during the trial
- antiretroviral therapy naive
Exclusion Criteria:
- patients in acute phase of HIV infection
- patients with ongoing opportunistic infection or AIDS-related malignancies; or with opportunistic infection within previous 3 months and still unstable within 14 days before inclusion
patients with the any of the following test results during screening for inclusion:
- WBC count < 2000/ul,
- neutrophil count < 1000/ul,
- Hb < 9g/dl,
- platelet count < 75000/ul,
- serum creatinine > 1.5 ULN,
- transaminases or alkaline phosphatase > 3 ULN,
- total bilirubin > 2 ULN,
- serum creatinine kinase > 2 ULN
- CCr < 60ml/min
- Pregnancy and breastfeeding
- Intravenous drug user
- Severe neuropathy or mental disorder
- history of alcohol abuse and unable to withdrawal
- Severe peptic ulcer disease
- Non-Chinese nationality
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Annen: TDF+3TC+EFV
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48
Tidsramme: 48 weeks
|
48 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96
Tidsramme: 96 weeks
|
96 weeks
|
|
Percentage of Participants With HIV-1 RNA < 40 Copies/mL at Week 96
Tidsramme: 96 weeks
|
96 weeks
|
|
Change From Baseline in CD4 count at Week 48
Tidsramme: Baseline and 48 weeks
|
Baseline and 48 weeks
|
|
Change From Baseline in CD4 count at Week 96
Tidsramme: Baseline and 96 weeks
|
Baseline and 96 weeks
|
|
Incidence of adverse events and laboratory abnormalities from baseline to week 48
Tidsramme: 48 weeks
|
48 weeks
|
|
Incidence of adverse events and laboratory abnormalities from baseline to week 96
Tidsramme: 96 weeks
|
96 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Fan H, Guo F, Hsieh E, Chen WT, Lv W, Han Y, Xie J, Li Y, Song X, Li T. Incidence of hypertension among persons living with HIV in China: a multicenter cohort study. BMC Public Health. 2020 Jun 1;20(1):834. doi: 10.1186/s12889-020-08586-9.
- Luo L, Wang N, Yue Y, Han Y, Lv W, Liu Z, Qiu Z, Lu H, Tang X, Zhang T, Zhao M, He Y, Shenghua H, Wang M, Li Y, Huang S, Li Y, Liu J, Tuofu Z, Routy JP, Li T. The effects of antiretroviral therapy initiation time on HIV reservoir size in Chinese chronically HIV infected patients: a prospective, multi-site cohort study. BMC Infect Dis. 2019 Mar 14;19(1):257. doi: 10.1186/s12879-019-3847-0.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- CACT1215
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