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Main
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Note: This record shows only the 20 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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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR2010030001953121 |
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Date of registration:
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02/03/2010 |
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Primary sponsor: |
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Public title:
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Second-line antiretrovirals - Food interaction study
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Scientific title:
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Evaluation of the steady-state pharmacokinetics of second-line antiretroviral drugs when administered under different meal conditions in HIV-infected Ugandan adults |
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Date of first enrolment:
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2010-03-15 |
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Target sample size:
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15 |
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Recruitment status: |
Not yet recruiting |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR2010030001953121 |
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Study type:
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interventional |
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Study design:
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Crossover: all participants receive all interventions in different sequence during study,
Non-randomised,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Margaret
Denty |
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Address:
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Infectious Diseases Institute, College of Health Sciences, Makerere University
Kampala
Uganda |
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Telephone:
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(256) 414 307319 |
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Email:
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mdenty@idi.co.ug |
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Affiliation:
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Regulatory Affairs Officer |
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Name:
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Mohammed
Lamorde |
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Address:
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Infectious Diseases Institute, College of Health Sciences, Makerere University
Kampala
Uganda |
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Telephone:
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(245) 772185590 |
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Email:
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mlamorde@idi.co.ug |
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Affiliation:
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Study Coordinator |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. HIV-infected male and non pregnant female adults b 18 and ` 65 years of age
2. On ART containing lopinavir/ritonavir (LPV/r) plus 2NRTI with undetectable viremia (most recent HIV-RNA performed over preceding 12 months measuring `400 copies/ml)
3. No use of herbal/traditional medications or other medication known to induce or inhibit cytochrome P450 in previous 2 weeks
4. Ability to provide full written informed consent
Exclusion criteria: 1. Anaemia ( Hemoglobin) ` 10 g/dl
2. Evidence of liver impairment ALT b 5 times upper limit of normal
3. Evidence of renal impairment ( serum creatinine b 300 )
4. Severe bacterial or viral infection (requiring hospitalization or parenteral antibiotics within 2 weeks of screening)
5. Vomiting or diarrhoea lasting greater than 2 weeks within one month of screening
6. Refusal to adhere to prescribed meal conditions during administration of LPV/r plus 2 NRTIs
Age minimum:
18 Year
Age maximum:
65 Year
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV/AIDS
null
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Primary Outcome(s)
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Plasma concentrations of antiretroviral drugs when administered under different meal conditions
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Source(s) of Monetary Support
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Health Research Board of Ireland
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