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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: |
PACTR2009120001702102 |
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Date of registration:
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24/11/2009 |
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Primary sponsor: |
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Public title:
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Food-Atripla pharmacokinetic study
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Scientific title:
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Evaluation of the pharmacokinetics of Atripla? with and without food in HIV-1 infected Ugandan adults |
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Date of first enrolment:
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Target sample size:
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Recruitment status: |
Open to recruitment: actively recruiting participa |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR2009120001702102 |
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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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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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+256-772185590 |
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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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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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+256-772185590 |
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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-1 infected male and non-pregnant female adults b18 years to ` 65 years age
2. Stable on antiretroviral therapy containing TDF, FTC plus EFV for at least 1 month
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 written informed consent
Exclusion criteria: 1. Anaemia (Hb ` 10g/dl)
2. Evidence of pre-existing liver impairment (ALT b 5 times upper limit of normal)
3. Evidence of renal impairment (serum creatinine b 300)
4. Severe viral or bacterial infection (requiring hospitalization or parenteral antibioticis within 2 weeks of screening).
5. Vomiting or diarrhea lasting greater than 2 weeks within one month of screening.
6. Refusal to adhere to prescribed meal conditions for TDF/FTC/EFV
administration.
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 agents administered with food or without food.
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Source(s) of Monetary Support
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Health Research Board Ireland
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