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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00872417
• Other study ID #: CACT0810
• Secondary ID: PUMCH
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 30, 2009
• Last updated: March 30, 2009
• Start date: March 2009
• Est. completion date: December 2010

Study information

• Verified date: March 2009
• Source: Peking Union Medical College
• Contact: Tai sheng LI, M.D
• Phone: 00861065295086
• Email: litsh[@]263.net
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 750
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immune Deficiency Syndrome
• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

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
• 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

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College	Ministry of Science and Technology of the People´s Republic of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Set up our own antiviral therapy guideline and drug side-effects, drug concentration and immune reconstitution result.		two years	Yes