Status:
COMPLETED
Drug Interaction Study Between Atovaquone and Antiretroviral Agents in HIV-1 Infected Patients
Lead Sponsor:
Radboud University Medical Center
Conditions:
HIV Infections
Malaria
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 atov...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- For healthy volunteers
- 18 - 65 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.
- 18 - 65 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
- Exclusion Criteria healthy volunteers:
- 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
- Exclusion criteria HIV patients:
- History of sensitivity/idiosyncrasy to atovaquone/proguanil or chemically related compounds or excipients.
- Suspicion of non-adherence to the HIV medication.
- Current diarrhoea.
- Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
- Inability to understand the nature and extent of the trial and the procedures required.
- 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 upper limit of normal
- Creatinine clearance \< 60 mL/min (calculated from serum creatinine).
- Any change in antiretroviral medication within 1 month immediately pre- ceding the dose of atovaquone/proguanil.
- Concomitant use of medications that interfere with atovaquone or proguanil pharmacokinetics: anti-coagulants, aurothioglucose, chloroquine, cimetidine, fluoxetine, fluvoxamine, metoclopramide, omeprazole, magnesiumtrisilicate, rifabutin, rifampin, tetracycline, typhoid vaccine, topiramate.
- Use of a HAART regime containing both lopinavir/ritonavir and another protease inhibitor or a NNRTI.
- Use of a HAART regime containing both atazanavir/ritonavir and another protease inhibitor or a NNRTI.
- Use of a HAART regime containing both efavirenz and one or more protease inhibitors or nevirapine.
- Active hepatobiliary or hepatic disease
- Alcohol abuse
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00421473
Start Date
March 1 2007
End Date
December 1 2008
Last Update
November 12 2020
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Alysis Zorggroep loc. Rijnstate
Arnhem, Gelderland, Netherlands, 6800 TA
2
Radboud University Medical Centre Nijmegen
Nijmegen, Gelderland, Netherlands, 6525 GA
3
Elisabeth hospital
Tilburg, North Brabant, Netherlands, 5022 GC
4
Leids Universitair Medisch Centrum
Leiden, South Holland, Netherlands, 2300 RC