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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Peking Union Medical College.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Ministry of Science and Technology of the People´s Republic of China
Information provided by:
Peking Union Medical College
ClinicalTrials.gov Identifier:
NCT00872417
First received: March 30, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Acquired Immune Deficiency Syndrome
HIV Infections
Drug: first line ARV (3TC+NVP+D4T or 3TC+NVP+AZT)
Drug: second line ARV therapy (3TC+TDF+LPV/RTV)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Research on the Antiretroviral Therapy and Immune Reconstitution on Chinese HIV/AIDS Patients

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Set up our own antiviral therapy guideline and drug side-effects, drug concentration and immune reconstitution result. [ Time Frame: two years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 750
Study Start Date: March 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment-naive
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)
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
No Intervention: TREATMENT-EXPERIENCED
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
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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00872417

Contacts
Contact: Tai sheng LI, M.D 00861065295086 litsh@263.net

Locations
China
Peking Union Medical College Hospital Not yet recruiting
Beijing, China, 100730
Contact: Yang HAN       hanyang@pumch.cn   
Sub-Investigator: Wei LU, M.D         
Sponsors and Collaborators
Peking Union Medical College
Ministry of Science and Technology of the People´s Republic of China
Investigators
Study Chair: Tai sheng LI, M.D PUMCH
  More Information

No publications provided by Peking Union Medical College

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Li Taisheng, MD, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT00872417     History of Changes
Other Study ID Numbers: CACT0810, PUMCH
Study First Received: March 30, 2009
Last Updated: March 30, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Peking Union Medical College:
HIV/AIDS
antiretroviral therapy
immune reconstitution

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lamivudine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on July 31, 2014