NCT00872417

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 31, 2009

Status Verified

March 1, 2009

Enrollment Period

9 months

First QC Date

March 30, 2009

Last Update Submit

March 30, 2009

Conditions

Acquired Immune Deficiency SyndromeHIV Infections

Keywords

HIV/AIDSantiretroviral therapyimmune reconstitution

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Set up our own antiviral therapy guideline and drug side-effects, drug concentration and immune reconstitution result.

    two years

Study Arms (3)

Treatment-naive

EXPERIMENTAL

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)

TREATMENT-EXPERIENCED

NO INTERVENTION

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.

drug resistance

EXPERIMENTAL

To explore the second line drugs for those drug resistance patients

Drug: second line ARV therapy (3TC+TDF+LPV/RTV)

Interventions

first line ARV (3TC+NVP+D4T or 3TC+NVP+AZT)DRUG

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

Treatment-naive
second line ARV therapy (3TC+TDF+LPV/RTV)DRUG

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

drug resistance

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Related Publications (5)

  • Fan H, Guo F, Hsieh E, Chen WT, Lv W, Han Y, Xie J, Li Y, Song X, Li T. Incidence of hypertension among persons living with HIV in China: a multicenter cohort study. BMC Public Health. 2020 Jun 1;20(1):834. doi: 10.1186/s12889-020-08586-9.

    PMID: 32487185DERIVED

  • Han Y, Li Y, Xie J, Qiu Z, Li Y, Song X, Zhu T, Li T. Week 120 efficacy of tenofovir, lamivudine and lopinavir/r-based second-line antiretroviral therapy in treatment-experienced HIV patients. PLoS One. 2015 Mar 30;10(3):e0120705. doi: 10.1371/journal.pone.0120705. eCollection 2015.

    PMID: 25821963DERIVED

  • Cao Y, Han Y, Xie J, Cui Q, Zhang L, Li Y, Li Y, Song X, Zhu T, Li T. Impact of a tenofovir disoproxil fumarate plus ritonavir-boosted protease inhibitor-based regimen on renal function in HIV-infected individuals: a prospective, multicenter study. BMC Infect Dis. 2013 Jul 1;13:301. doi: 10.1186/1471-2334-13-301.

    PMID: 23815472DERIVED

  • Kou H, Du X, Li Y, Xie J, Qiu Z, Ye M, Fu Q, Han Y, Zhu Z, Li T. Comparison of nevirapine plasma concentrations between lead-in and steady-state periods in Chinese HIV-infected patients. PLoS One. 2013;8(1):e52950. doi: 10.1371/journal.pone.0052950. Epub 2013 Jan 24.

    PMID: 23359265DERIVED

  • Wang H, Li Y, Zhang C, Han Y, Zhang X, Zhu T, Li T. Immunological and virological responses to cART in HIV/HBV co-infected patients from a multicenter cohort. AIDS. 2012 Sep 10;26(14):1755-63. doi: 10.1097/QAD.0b013e328355ced2.

    PMID: 22614885DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Tai sheng LI, M.D

    PUMCH

    STUDY CHAIR

Central Study Contacts

Tai sheng LI, M.D

CONTACT

00861065295086litsh@263.net

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 30, 2009

First Posted

March 31, 2009

Study Start

March 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

March 31, 2009

Record last verified: 2009-03

Locations

CN(1)