Clinical trial NCT00872417: Study on the Antiviral Therapy and Immune Reconstitution of Chinese HIV/AIDS Patients
Official title: Research on the Antiretroviral Therapy and Immune Reconstitution on Chinese HIV/AIDS Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acquired Immune Deficiency Syndrome
HIV Infections
Keywords: HIV/AIDS
antiretroviral therapy
immune reconstitution
Lead sponsor: Peking Union Medical College
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology of the People´s Republic of China
First posted: 2009-03-31
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will recruit 520 treatment-naive and 150 treatment-experienced patients to take the first line or second line of antiviral therapy. This study aims to set up a well-trained clinical and laboratory team in China, to explore the effects and side-effects of the first-line and the second line of ARV treatment in Chinese HIV/AIDS adult patients, to investigate the side-effects of ARV drugs, such as hepatotoxicity, lipoatrophy, cardiovascular influence, to explore the pharmacokinetics/pharmacodynamics (PK/PD) of Chinese generic ARV regiments and effective drug concentrations and to explore primary and secondary drug resistance in China and the immune reconstitution characters of long term ARV in Chinese adult AIDS patients. This study might provide more practical and optimizing prove for the treatment guideline for resource limited areas.

Detailed description: Three arms will be studied in this research, 520 naive-treatment patients would be randomized to two groups, taking the generic drugs 3TC+D4T+NVP or AZT+3TC+NVP, 6 months later half of the 3TC+D4T+NVP group will switch to AZT+3TC+NVP, in order to observe the efficiency and safety of the first line drugs. Arm 2 will recruit 100 patients who are taking ARV for about three years already. Arm 3 will recruit 150 patients who have a Viral load of more than 1000 copies/ml, i.e., drug resistance. The second line drug 3TC+TDF+LPV/RTV will given to them and the safety and efficiency will be observed. All patients should be explored in terms of the clinical features, drugs side-effects, and immunological and viral response. The drug concentration and the metabolism changes would be explored also. Also the immune reconstitution will be studied for all patients. This study will be the first large-scale, multicentered, randomised, prospective ARV therapy study in China for HIV/AIDs patients. The result would provide proves for further practical antiviral therapy for China or other resource limited countries.

Eligibility criteria: Inclusion Criteria:

* age between 18-65 years
* HIV seropositive and confirmed by western blot
* antiretroviral therapy naive for arm 1
* CD4 cell count \< 350/mm3
* good adherence and follow up in the same place

Exclusion Criteria:

* pregnancy and breastfeeding
* AIDS defining illness or any infectious disease occured in one month but still unstable within 14 days
* with WBC \< 2000/ul, neutrophil count \< 1000/ul, hemoglobin \< 9 g/dl, platelet count \< 75000/ul, amylase \> 2 ULN, transaminase or alkaline phosphatase or total bilirubin \> 2 ULN, creatinine \> 2 ULT.
* present acute or chronic pancreatitis
* intravenous drug user
* peripheral nephropathy
* severe nephropathy or mental disorder
* severe gastral ulcer
* heart or brain arthrosclerosis

Primary outcomes:
measure: To set up a platform of antiviral therapy network all of CHINA, to obtain evidence to make first line or second line ARV treatment strategy for HIV/AIDS patients in resource limited areas.
timeFrame: two years
Secondary outcomes:
measure: Set up our own antiviral therapy guideline and drug side-effects, drug concentration and immune reconstitution result.
timeFrame: two years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: PUMCH
name: Tai sheng LI, M.D
role: STUDY_CHAIR
References:
citation: 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.
citation: Han Y, Li Y, Xie J, Qiu Z, Li Y, Song X, Zhu T, Li T. Week 120 efficacy of tenofovir, lamivudine and lopinavir/r-based second-line antiretroviral therapy in treatment-experienced HIV patients. PLoS One. 2015 Mar 30;10(3):e0120705. doi: 10.1371/journal.pone.0120705. eCollection 2015.
citation: Cao Y, Han Y, Xie J, Cui Q, Zhang L, Li Y, Li Y, Song X, Zhu T, Li T. Impact of a tenofovir disoproxil fumarate plus ritonavir-boosted protease inhibitor-based regimen on renal function in HIV-infected individuals: a prospective, multicenter study. BMC Infect Dis. 2013 Jul 1;13:301. doi: 10.1186/1471-2334-13-301.
citation: Kou H, Du X, Li Y, Xie J, Qiu Z, Ye M, Fu Q, Han Y, Zhu Z, Li T. Comparison of nevirapine plasma concentrations between lead-in and steady-state periods in Chinese HIV-infected patients. PLoS One. 2013;8(1):e52950. doi: 10.1371/journal.pone.0052950. Epub 2013 Jan 24.
citation: Wang H, Li Y, Zhang C, Han Y, Zhang X, Zhu T, Li T. Immunological and virological responses to cART in HIV/HBV co-infected patients from a multicenter cohort. AIDS. 2012 Sep 10;26(14):1755-63. doi: 10.1097/QAD.0b013e328355ced2.