Clinical Trials

MainTitle

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

The recruitment status of this study is unknown.

Verified March 2009

Sponsor
Peking Union Medical College

Collaborator
Ministry of Science and Technology of the People´s Republic of China

Information provided by (Responsible Party)
Peking Union Medical College
ClinicalTrials.gov Identifier
NCT00872417

First received: March 30, 2009
Last updated: March 30, 2009
Last Verified: March 2009
History of Changes
Purpose

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
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Research on the Antiretroviral Therapy and Immune Reconstitution on Chinese HIV/AIDS Patients

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

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

Eligibility

Ages Eligible for Study: 18 Years to 65 Years  
Sexes Eligible for Study: All  
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

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

More Information


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  

Keywords provided by Peking Union Medical College:

HIV/AIDS
antiretroviral therapy
immune reconstitution

Additional relevant MeSH terms:
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Lamivudine

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.