Drug Interaction Study Between Atovaquone and Antiretroviral Agents in HIV-1 Infected Patients
Drug Interactions Between ATOvaquone Used in MAlaria Prophylaxis and Antiretroviral Agents in HIV-1 Infected Patients (ATOMA)
1 other identifier
interventional
79
1 country
5
Brief Summary
Malarone® (atovaquone/proguanil) is frequently used in malaria prophylaxis. Unfortunately, there are indications that certain anti-HIV agents may decrease atovaquone plasma levels by induction of atovaquone metabolism. For travelling HIV patients, the clinical consequences of these possible drug drug interactions are serious, since a diminished exposure to the anti-malarial drug will result in suboptimal prophylaxis of malaria and potential development of drug resistant strains of Plasmodium falciparum. The purpose of this study is to find out if HIV patients using HAART regimes with either lopinavir/ritonavir, atazanavir/ritonavir or efavirenz have lower atovaquone plasma levels than healthy volunteers after a single dose of atovaquone/proguanil.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hiv-infections
Started Mar 2007
Shorter than P25 for phase_4 hiv-infections
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2007
CompletedFirst Posted
Study publicly available on registry
January 12, 2007
CompletedStudy Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedNovember 12, 2020
November 1, 2020
1.8 years
January 11, 2007
November 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic blood samples will be taken just before dosing Malarone, and 12 samples in the time between 0,5 hour and 168 hours after dosing.
Secondary Outcomes (2)
Blood will be taken for genotyping of CYP2C19 at study day 1.
HIV-1 RNA and CD4 determination will be done (HIV patients only) at inclusion screening
Interventions
Eligibility Criteria
You may qualify if:
- For healthy volunteers
- years
- smoking habits \< 10 cigarettes, 2 cigars or 2 pipes
- BMI between 18 and 30 kg/m2
- able and willing to sign informed consent form
- subject is in a good age-appropriate health condition
- subject has a normal blood pressure and pulse rate
- For HIV patients
- HIV-infected as documented by positive HIV antibody test and confirmed by Western Blot.
- CD4+ \> 200 \* 10E6 per Liter.
- years
- BMI between 18 and 30 kg/m2
- able and willing to sign informed consent form
- use of lopinavir/ritonavir, atazanavir/ritonavir or efavirenz for at least 1 month in a dose of 400/100mg bid, 300/100 mg QD, or 600 mg QD respectively
You may not qualify if:
- History of sensitivity/idiosyncrasy to atovaquone/proguanil or chemically related compounds or excipients.
- Positive HIV test.
- Positive HbsAg test (hepatitis B) or positive hepatitis C test.
- Therapy with any drug (for two weeks preceding dosing), except for paracetamol.
- Creatinine clearance \< 60 mL/min (calculated from serum creatinine)
- Current diarrhoea.
- Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
- History of or current abuse of drugs, alcohol or solvents.
- Inability to understand the nature and extent of the trial and the procedures required.
- Participation in a drug trial within 60 days prior to the first dose.
- Donation of blood within 60 days prior to the first dose.
- Pregnant female (as confirmed by an HCG test performed less than 3 weeks before the first dose) or breast-feeding female.
- Abnormal serum transaminases, determined as levels being \> 3 times up-per limit of normal
- Febrile illness within 3 days before the first dose
- History of sensitivity/idiosyncrasy to atovaquone/proguanil or chemically related compounds or excipients.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Alysis Zorggroep loc. Rijnstate
Arnhem, Gelderland, 6800 TA, Netherlands
Radboud University Medical Centre Nijmegen
Nijmegen, Gelderland, 6525 GA, Netherlands
Elisabeth hospital
Tilburg, North Brabant, 5022 GC, Netherlands
Leids Universitair Medisch Centrum
Leiden, South Holland, 2300 RC, Netherlands
Erasmus MC
Rotterdam, South Holland, 3000 CA, Netherlands
Related Publications (1)
van Luin M, Van der Ende ME, Richter C, Visser M, Faraj D, Van der Ven A, Gelinck L, Kroon F, Wit FW, Van Schaik RH, Kuks PF, Burger DM. Lower atovaquone/proguanil concentrations in patients taking efavirenz, lopinavir/ritonavir or atazanavir/ritonavir. AIDS. 2010 May 15;24(8):1223-6. doi: 10.1097/QAD.0b013e3283389129.
PMID: 20299957RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
D.M. Burger, Dr.
Radboud University Medical Centre Nijmegen
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 11, 2007
First Posted
January 12, 2007
Study Start
March 1, 2007
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
November 12, 2020
Record last verified: 2020-11