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HIV InfectionsPhase 4NCT00421473

Drug Interaction Study Between Atovaquone and Antiretroviral Agents in HIV-1 Infected Patients

A Phase 4 study testing Atovaquone / Proguanil in people with HIV Infections and Malaria, run by Radboud University Medical Center at 5 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections, Malaria
What is being tested?
Atovaquone / Proguanil
How many people
79 participants
Where
5 sitesNetherlands
Study dates
Mar 2007to Dec 2008
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
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  • 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.
  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Netherlands5 sites

  • Alysis Zorggroep loc. Rijnstate

    Arnhem, Gelderland, 6800 TA

  • Leids Universitair Medisch Centrum

    Leiden, South Holland, 2300 RC

  • Radboud University Medical Centre Nijmegen

    Nijmegen, Gelderland, 6525 GA

  • Erasmus MC

    Rotterdam, South Holland, 3000 CA

  • Elisabeth hospital

    Tilburg, North Brabant, 5022 GC

Other trials in Netherlands

About this study

Official title: Drug Interactions Between ATOvaquone Used in MAlaria Prophylaxis and Antiretroviral Agents in HIV-1 Infected Patients (ATOMA)

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.

Being tested
Atovaquone / Proguanil
Keywords
HIV, Malaria prophylaxis, Treatment Experienced
Medical subject headings
HIV Infections, Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atovaquone / ProguanilDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

  1. Blood will be taken for genotyping of CYP2C19 at study day 1.

  2. HIV-1 RNA and CD4 determination will be done (HIV patients only) at inclusion screening

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionDec 2008
  4. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00421473
Sponsor's protocol ID
UMCN-AKF 06.02
Status last verified
Nov 2020
First submitted
11 Jan 2007
Last updated
12 Nov 2020
Results posted
No

Publications

  • 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.

    PubMed 20299957

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Atovaquone / Proguanil in people with HIV Infections and Malaria, run by Radboud University Medical Center at 5 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00421473, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.

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