Overview

Raltegravir-based Antiretroviral Therapy for Resistant HIV-1 Infection

Status:
Unknown status
Trial end date:
2015-12-01
Target enrollment:
0
Participant gender:
All
Summary
This study is to evaluate the safety and efficacy of RAL-based regimen in treatment-experienced patients with resistant HIV infection
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Peking Union Medical College
Treatments:
Raltegravir Potassium
Criteria
Inclusion Criteria:

1. Age between 18-65 years

2. HIV seropositive and confirmed by western blot

3. have taken first line antiretroviral therapy for over one year and have any one of the
criteria listed below (viral load of all the patients meeting these criteria should be
confirmed at PUMCH laboratory)

1. Viral load more than 400 copies/ml

2. Viral rebound (confirmed by HIV RNA more than 400 copies/ml after virologic
suppression)

3. When viral load cannot be monitored, patients experience immunologic failure who
meet at least one of the criteria listed below will be enrolled:

- CD4 count equal to or lower than baseline level with first-line therapy,on
two occasions over three months apart

- CD4 count with 50 percentage fall from the on-treatment peak value

- persistent CD4 count levels less than 100 cells/μl after over one-year
antiretroviral therapy

Exclusion Criteria:

- Previous use of protease inhibitors

- Previous use of integrase inhibitors

- Pregnancy and breastfeeding

- poor compliance and drug interaction,

- opportunistic infections or malignancy at recruitment; or opportunistic infections
within three months but still unstable within 14 days prior to recruitment

- HBsAg positive

- patients with the any of the following test results during screening for inclusion:
WBC count<2000/μl, neutrophil count<1000/μl, Hb<9g/dl, platelet count<75000/μl, serum
creatinine>1.5 ULN, transaminases or alkaline phosphatase >3 ULN, total bilirubin>2
ULN, serum creatinine kinase>2 ULN

- CCr<60 ml/min

- Current intravenous drug use

- Severe neuropathy or mental disorder

- history of alcohol abuse and unable to withdrawal

- Severe peptic ulcer