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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00872417
Recruitment Status : Unknown
Verified March 2009 by Peking Union Medical College.
Recruitment status was:  Not yet recruiting
First Posted : March 31, 2009
Last Update Posted : March 31, 2009
Ministry of Science and Technology of the People´s Republic of China
Information provided by:
Peking Union Medical College

March 30, 2009
March 31, 2009
March 31, 2009
March 2009
December 2009   (Final data collection date for primary outcome 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. [ Time Frame: two years ]
Same as current
No Changes Posted
Set up our own antiviral therapy guideline and drug side-effects, drug concentration and immune reconstitution result. [ Time Frame: two years ]
Same as current
Not Provided
Not Provided
Study on the Antiviral Therapy and Immune Reconstitution of Chinese HIV/AIDS Patients
Research on the Antiretroviral Therapy and Immune Reconstitution on Chinese HIV/AIDS Patients
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.
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
  • Acquired Immune Deficiency Syndrome
  • HIV Infections
  • Drug: first line ARV (3TC+NVP+D4T or 3TC+NVP+AZT)
    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
  • Drug: second line ARV therapy (3TC+TDF+LPV/RTV)
    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
  • Experimental: Treatment-naive
    To explore the efficiency and safety of generic antiretroviral drugs for 520 treatment-naive HIV/AIDS patients
    Intervention: 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.
  • Experimental: drug resistance
    To explore the second line drugs for those drug resistance patients
    Intervention: Drug: second line ARV therapy (3TC+TDF+LPV/RTV)

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
December 2010
December 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Li Taisheng, MD, Peking Union Medical College Hospital
Peking Union Medical College
Ministry of Science and Technology of the People´s Republic of China
Study Chair: Tai sheng LI, M.D PUMCH
Peking Union Medical College
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP