A Phase 4 interventional study of first line ARV (3TC+NVP+D4T or 3TC+NVP+AZT) and second line ARV therapy (3TC+TDF+LPV/RTV) in Acquired Immune Deficiency Syndrome and HIV Infections, sponsored by Peking Union Medical College. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-03-31.
Sponsored by Peking Union Medical College · Phase 4, Interventional, and Treatment
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.
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's planned enrollment of 750 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.
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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)
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.
To explore the second line drugs for those drug resistance patients
Drug: second line ARV therapy (3TC+TDF+LPV/RTV)
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
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
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.
Time frame: two years
Set up our own antiviral therapy guideline and drug side-effects, drug concentration and immune reconstitution result.
Time frame: two years
This study is status unknown, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.
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Peking Union Medical College