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

March 30, 2009 updated by: Peking Union Medical College

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

750

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Tai sheng LI, M.D
  • Phone Number: 00861065295086
  • Email: litsh@263.net

Study Locations

  • China
      • Beijing, China, 100730
        • Peking Union Medical College Hospital
        • Contact:
        • Sub-Investigator:
          • Wei LU, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
two years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College

Collaborators

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

Investigators

  • Study Chair: Tai sheng LI, M.D, PUMCH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

March 30, 2009

First Submitted That Met QC Criteria

March 30, 2009

First Posted (Estimate)

March 31, 2009

Study Record Updates

Last Update Posted (Estimate)

March 31, 2009

Last Update Submitted That Met QC Criteria

March 30, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CACT0810
  • PUMCH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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