Raltegravir-based Antiretroviral Therapy for Resistant HIV-1 Infection
1 other identifier
interventional
300
1 country
1
Brief Summary
This study is to evaluate the safety and efficacy of RAL-based regimen in treatment-experienced patients with resistant HIV infection
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2012
CompletedFirst Posted
Study publicly available on registry
May 1, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMay 1, 2013
April 1, 2013
2.6 years
August 25, 2012
April 26, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of participants with HIV-1 RNA < 400 copies/mL at week 48
48 weeks
Secondary Outcomes (3)
Percentage of participants with HIV-1 RNA < 40 copies/mL at week 48
48 weeks
Change from baseline in CD4 count at week 48
Baseline and 48 weeks
Incidence of adverse events and laboratory abnormalities in the two treatment arms from baseline to week 48
through week 48
Study Arms (2)
RAL +TDF+ LPV/r
ACTIVE COMPARATORArm A: RAL +TDF+ KELETRA(LPV/r) Group A will be assigned with RAL+TDF+LPV/r.
3TC+ TDF+LPV/r
ACTIVE COMPARATORArm B: 3TC+ TDF+KELETRA(LPV/r) Group B will be assigned with 3TC+TDF+LPV/r
Interventions
Eligibility Criteria
You may qualify if:
- Age between 18-65 years
- HIV seropositive and confirmed by western blot
- 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)
- Viral load more than 400 copies/ml
- Viral rebound (confirmed by HIV RNA more than 400 copies/ml after virologic suppression)
- 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
You may not qualify if:
- 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
- CCr\<60 ml/min
- Current intravenous drug use
- Severe neuropathy or mental disorder
- history of alcohol abuse and unable to withdrawal
- Severe peptic ulcer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, 100730, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- director of the Department of Infectious Disease
Study Record Dates
First Submitted
August 25, 2012
First Posted
May 1, 2013
Study Start
May 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
May 1, 2013
Record last verified: 2013-04