Europe-Africa Research Network for Evaluation of Second-line Therapy (EARNEST)
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ClinicalTrials.gov Identifier: NCT00988039 |
Recruitment Status
:
Completed
First Posted
: October 1, 2009
Last Update Posted
: April 4, 2014
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Tracking Information | ||||
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First Submitted Date ICMJE | September 30, 2009 | |||
First Posted Date ICMJE | October 1, 2009 | |||
Last Update Posted Date | April 4, 2014 | |||
Study Start Date ICMJE | March 2010 | |||
Actual Primary Completion Date | January 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Good HIV disease control defined as a composite endpoint consisting of all of: - No new WHO stage 4 events - CD4 count >250 cells/mm3 - viral load <10,000 copies/ml or >10,000 copies/ml with no PI resistance mutations [ Time Frame: week 96 ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00988039 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Europe-Africa Research Network for Evaluation of Second-line Therapy | |||
Official Title ICMJE | A Randomised Controlled Trial to Evaluate Options for Second-line Therapy in Patients Failing a First-line 2NRTI + NNRTI Regimen in Africa | |||
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 following WHO-defined failure on a first-line nucleoside reverse transcriptase inhibitor (NRTI) and NNRTI-containing regimen with probable extensive NRTI and NNRTI resistance mutations. | |||
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 failing first-line therapy in roll-out programmes often have extensive NRTI resistance mutations that may compromise the efficacy of the NRTI drugs used in second-line therapy and it is likely that the virological potency of the second-line regimen is mostly due to the bPI. It is possible that the contribution of the NRTI drugs to efficacy may be outweighed by additional toxicity and cost. It is also possible that replacing the NRTI drugs with a new class of drug (integrase inhibitors) will improve outcome from second-line therapy, although if the boosted protease inhibitor alone is providing close to optimal response, incremental gains from adding a new class may be small. The principal aims are to determine whether, in patients failing a first-line NRTI and NNRTI-containing regimen:
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
1277 | |||
Original Estimated Enrollment ICMJE |
1200 | |||
Actual Study Completion Date | January 2014 | |||
Actual Primary Completion Date | January 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 12 Years and older (Child, Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Kenya, Malawi, Uganda, Zambia, Zimbabwe | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00988039 | |||
Other Study ID Numbers ICMJE | U.1228.03.004.00021.01 IP_2007_33011_003 ISRCTN37737787 |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Justine Boles, Medical Research Council | |||
Study Sponsor ICMJE | Justine Boles | |||
Collaborators ICMJE | European and Developing Countries Clinical Trials Partnership (EDCTP) | |||
Investigators ICMJE |
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PRS Account | Medical Research Council | |||
Verification Date | April 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |