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

NCT00872417 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2009-03-31

No results posted yet for this study

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.

Conditions

  • Acquired Immune Deficiency Syndrome
  • HIV Infections

Interventions

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

Sponsors & Collaborators

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

    collaborator OTHER_GOV

  • Peking Union Medical College

    lead OTHER

Principal Investigators

  • Tai sheng LI, M.D · PUMCH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-12-31
Completion
2010-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00872417 on ClinicalTrials.gov