Status:
COMPLETED
Europe-Africa Research Network for Evaluation of Second-line Therapy
Lead Sponsor:
Justine Boles
Collaborating Sponsors:
European and Developing Countries Clinical Trials Partnership (EDCTP)
Conditions:
Human Immunodeficiency Virus
HIV
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
The trial aim is to ascertain what, if anything, needs to be combined with a boosted protease inhibitor (bPI) backbone in second-line therapy in order to maximize the chance of a good clinical outcome...
Detailed Description
The standard of care for second-line HIV therapy in patients who have failed a first-line NNRTI-based regimen is to combine a boosted protease inhibitor (bPI) with two (new) NRTIs. However, patients f...
Eligibility Criteria
Inclusion
- Previously documented HIV infection on at least one standard antibody-based test
- Age 12 years and above
- Taking 2NRTI + NNRTI-based regimen continuously for at least 12 months
- Naive to protease inhibitor therapy
- Good adherence to ART in the 12 weeks prior to screening defined as missing medication on no more than 3 days in the prior month
- Clinically stable and receiving treatment for any known opportunistic infections
- HIV treatment failure defined by one or more of clinical, immunological or virological criteria defined in the protocol, including VL and CD4 at screening visit
- Willing and able to give informed consent
- Able to attend for regular study follow up visits
Exclusion
- Any major clinical contra-indications to the use of bPI, the NRTIs that are available to be selected for a second-line regimen or raltegravir
- Known Hepatitis B carrier (Hepatitis B surface antigen positive if tested)
- Requires concomitant medication with known major interactions with study drugs for which drug substitutions or dose alterations are not available or acceptable
- Women who are currently pregnant or breastfeeding
- Current participation in another clinical trial involving a treatment intervention (may be permitted in some circumstances, but must be discussed with MRC CTU)
- Life expectancy of less than one month in the opinion of the treating physician
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
1277 Patients enrolled
Trial Details
Trial ID
NCT00988039
Start Date
March 1 2010
End Date
January 1 2014
Last Update
April 4 2014
Active Locations (14)
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1
AMPATH Centre at Moi Teaching Referral Hospital
Eldoret, Kenya
2
University of Malawi
Blantyre, Malawi
3
Mzuzu Central Hospital
Mzuzu, Malawi
4
Joint Clinical Research Centre
Fort Portal, Uganda