Study on the Antiviral Therapy and Immune Reconstitution of Chinese HIV/AIDS Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Research on the Antiretroviral Therapy and Immune Reconstitution on Chinese HIV/AIDS Patients

Conditions
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Acquired Immune Deficiency Syndrome, HIV Infections

Intervention / Treatment
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* Drug: first line ARV (3TC+NVP+D4T or 3TC+NVP+AZT)
* Drug: second line ARV therapy (3TC+TDF+LPV/RTV)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment-naive<br>To explore the efficiency and safety of generic antiretroviral drugs for 520 treatment-naive HIV/AIDS patients | Drug: first line ARV (3TC+NVP+D4T or 3TC+NVP+AZT)<br>* use the generic regimens: 3TC+NVP+D4T or 3TC+NVP+AZT to initiate the ARV therapy, after 6 months, half of the group 3TC+NVP+D4T patients switch to the the treatment of 3TC+NVP+AZT<br>|
| No Intervention: TREATMENT-EXPERIENCED<br>To explore the long term ARV of treatment-experienced patients who have no sign of drug resistance; to explore the long term efficiency and safety and drug sife effects of ARV in HIV/AIDS patients. These patients have taken ARV for approximately 3 years already. | |
| Experimental: drug resistance<br>To explore the second line drugs for those drug resistance patients | Drug: second line ARV therapy (3TC+TDF+LPV/RTV)<br>* Use 3TC+TDF+LPV/RTV to treat those drug resistance patients, to explore the efficiency and safety of the second line ARV available in China<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Set up our own antiviral therapy guideline and drug side-effects, drug concentration and immune reconstitution result. |  | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV/AIDS, antiretroviral therapy, immune reconstitution