- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01844310
Raltegravir-based Antiretroviral Therapy for Resistant HIV-1 Infection
April 26, 2013 updated by: LI Taisheng, Peking Union Medical College
Raltegravir-based Antiretroviral Therapy for Resistant HIV-1 Infection in China
This study is to evaluate the safety and efficacy of RAL-based regimen in treatment-experienced patients with resistant HIV infection
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
In our study, both efficacy and safety of raltegravir(RAL)-based therapy will be assessed.
300 treatment-experienced patients with drug-resistant HIV will be randomized to two arms (2:1).
Group A (n=200) will be assigned with RAL-based regimen (RAL+TDF+LPV/r).Group B (n=100) will be assigned with current second-line regimen in China (3TC+TDF+LPV/r).
Both virological and immunological profiles and responses at baseline and at week 4, 8, 12, 24, 36, and 48 will be evaluated.
This study will be the first large-scale, multicenter, randomized, prospective RAL-based therapy study in China for HIV/AIDs patients.
The result will provide proves for further practical antiviral therapy for China or other resource-limiting countries.
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Not Applicable
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: Taisheng Li, MD
- Phone Number: 86-10-69155086
- Email: litsh@263.net
Study Locations
-
-
-
Beijing, China, 100730
- Peking Union Medical College Hospital
-
Contact:
- Wei Lv, MD
- Phone Number: 86-10-69155082
- Email: lvweipumch@163.com
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Principal Investigator:
- Taisheng Li, MD
-
-
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
16 years to 63 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
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
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
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: RAL +TDF+ LPV/r
Arm A: RAL +TDF+ KELETRA(LPV/r) Group A will be assigned with RAL+TDF+LPV/r.
|
Group A will be assigned with RAL-based regimen (RAL+TDF+LPV/r).
|
Active Comparator: 3TC+ TDF+LPV/r
Arm B: 3TC+ TDF+KELETRA(LPV/r) Group B will be assigned with 3TC+TDF+LPV/r
|
Group B will be assigned with 3TC+TDF+LPV/r
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of participants with HIV-1 RNA < 400 copies/mL at week 48
Time Frame: 48 weeks
|
48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of participants with HIV-1 RNA < 40 copies/mL at week 48
Time Frame: 48 weeks
|
48 weeks
|
Change from baseline in CD4 count at week 48
Time Frame: Baseline and 48 weeks
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Baseline and 48 weeks
|
Incidence of adverse events and laboratory abnormalities in the two treatment arms from baseline to week 48
Time Frame: through week 48
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through week 48
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
May 1, 2013
Primary Completion (Anticipated)
December 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
August 25, 2012
First Submitted That Met QC Criteria
April 26, 2013
First Posted (Estimate)
May 1, 2013
Study Record Updates
Last Update Posted (Estimate)
May 1, 2013
Last Update Submitted That Met QC Criteria
April 26, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CACT1215-01
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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