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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01255371 |
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Date of registration:
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29/11/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Multicentre Trial of Second-line Antiretroviral Treatment Strategies in African Adults Using Atazanavir or Lopinavir/Ritonavir
ALISA |
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Scientific title:
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A Multicenter Phase III Trial of Second-line Antiretroviral Treatment Strategies in African Adults (Tanzania Ans South Africa) Using Atazanavir or Lopinavir/Ritonavir |
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Date of first enrolment:
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March 2012 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT01255371 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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South Africa
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Tanzania
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Contacts
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Name:
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Eric Delaporte |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut de Recherche pour le Developpement, France |
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Name:
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Alexandra Calmy |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Geneva, Switzerland |
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Name:
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Issakwisa Mwakyula |
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Address:
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Telephone:
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Email:
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Affiliation:
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NIMR-Mbeya Medical Research Program-Mbeya Referral Hospital, Tanzania |
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Name:
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Mzileni O Mogiyana |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Limpopo |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- age 18 and above
- out patient
- documented HIV-1 infection
- first line treatment failure:
- after first-line antiretroviral treatment with a combination including a
non-nucleoside reverse transcriptase inhibitor and two nucleoside reverse
transcriptase inhibitors
- two measurements of plasma HIV RNA levels > 1000 copies/mL after at least 6
months of uninterrupted treatment or without any major modification
- satisfactory compliance (>80%) to 1st line antiretroviral treatment
- signed informed consent
- agreement for contraception for women of childbearing age
Exclusion Criteria:
- HIV-2 infection or HIV-1/HIV-2 coinfection
- uncontrolled, ongoing opportunistic infection or of any severe or progressive disease
including active TB
- first line antiretroviral treatment with a protease inhibitor or tenofovir
- ongoing treatment with rifampicin
- severe hepatic insufficiency (PT < 50%)
- ALT < 3 times the upper limit of normal
- creatinine clearance calculated by Cockcroft's formula < 50 mL/min
- Hb <=8 g/dL; platelets < 50,000 cells/mm3; neutrophils < 500 cells/mm3
- pregnancy and lactation
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV
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Intervention(s)
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Drug: Atazanavir
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Drug: Lopinavir
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Primary Outcome(s)
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Virological response
[Time Frame: 48 weeks]
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Secondary Outcome(s)
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Clinical course of HIV infection
[Time Frame: Up to 48 weeks]
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Virological response
[Time Frame: 12 and 24 weeks]
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Adherence assessment
[Time Frame: At each protocol visit : week 2, 4, 12, 24, 36 and 48]
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Tolerance assessment
[Time Frame: 24 and 48 weeks]
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Hepatitis B evaluation
[Time Frame: At entry]
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Immunologic response
[Time Frame: 24 and 48 weeks]
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Viral resistance
[Time Frame: 12, 24 and 48 weeks]
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Secondary ID(s)
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ANRS 12221 ALISA
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IP.07.33011.004
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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