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MalariaPhase 4NCT00790881

Artemether/Lumefantrine and Nevirapine Interaction Study in HIV-infected Adults

A Phase 4 study testing Artemether/Lumefantrine and Artemether/ lumefantrine in people with Malaria and HIV, run by University of Cape Town at 1 site in South Africa.

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

Despite the clinical significance of potential interactions between antimalarials and antiretrovirals, no drug interaction studies have been published and there is an urgent need to address this gap in current knowledge. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malaria, HIV
What is being tested?
Artemether/Lumefantrine and Artemether/ lumefantrine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteSouth Africa
Study dates
Oct 2008to Dec 2009
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed and given ample time and opportunity to think about participation and willing and able to comprehend and comply with all trial requirements. The participant has given written informed consent to participate in the study and to abide by study restrictions.
  • Male or female subjects older than 18 years of age.
  • HIV-infected as documented by positive HIV-antibody test and confirmed by Western blot.
  • Body weight more than 35kg with a body mass index (BMI) ranging between 18.5 to 30kg/m2 inclusive (See Appendix 16.2).
  • Karnofsky score above 70 (See Appendix 16.5).
  • CD4 count ≥ 200 cells/mm3
  • Patients on NVP-based cART at stable doses without significant toxicity for at least 6 weeks at screening (Group 2 only).

Who cannot join

  • Patients diagnosed with Plasmodium falciparum malaria
  • Contraindications to artemether/lumefantrine:
  • Hypersensitivity to the artemether, lumefantrine or to any of the excipients of Coartem®.
  • Patients with severe malaria according to WHO definition.
  • Pregnant (as confirmed by an HCG test performed at screening) or breast-feeding female.
  • Patients with a family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to prolong the QTc interval such as patients with a history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease.
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  • Patients with known disturbances of electrolyte balance e.g. hypokalaemia or hypomagnesaemia.
  • Patients taking any drug which is metabolised by the cytochrome enzyme CYP2D6 (e.g. flecainide, metoprolol, imipramine, amitriptyline, clomipramine).
  • Patients taking drugs that are known to prolong the QTc interval such as antiarrhythmics of classes IA and III, neuroleptics, antidepressive agents, certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones, imidazole, and triazole antifungal agents, certain non-sedating antihistaminics (terfenadine, astemizole), cisapride.
  • Contraindication to nevirapine:
  • Hypersensitivity to nevirapine or any of the excipients of Aspen Nevirapine®.
  • Severe hepatic dysfunction: Child-Pugh class B or C and in endstage renal failure in patients not on haemodialysis.
  • Aspartate transaminase (AST) or alanine aminotransferase (ALT) > 5 x upper limit of normal (ULN).
  • History of severe rash, rash accompanied by constitutional symptoms; hypersensitivity syndrome, or clinical hepatitis due to nevirapine.
  • Haemoglobin below 8.5g/dL for female and 9.5g/dL for male subjects.
  • Pharmacokinetic exclusion criteria:
  • Relevant history or current condition(s) that might interfere with drug absorption, distribution, metabolism or excretion.
  • Current smokers, or subjects who have stopped smoking less than 3 months prior to the date of screening.
  • History of or current substance abuse problem or a positive urine screen for drugs of abuse.
  • History of or current compulsive alcohol abuse problem.
  • The subject has consumed any alcohol, grapefruit or caffeine-containing products (ie tea, coffee, cola, chocolate) within 24 hours before the first dose of AL during each PK profile.
  • The subject has participated in strenuous exercise within 24 hours before the first IP administration.
  • General exclusion criteria:
  • Severely ill or suffering from any serious underlying disease (particularly cardiac, hepatic or renal disease) that in the opinion of the Investigator would make the participant unsuitable for the study in terms of their safety or study analysis.
  • The volunteer has participated in another study with any investigational product within 8 weeks before the first administration of the current investigational products, or until at least 5 x t½ elimination has lapsed, whichever is the greater.
  • Subjects who, in the opinion of the Investigator, should not participate in the study.

Trial locations and contacts

1 site in 1 country.

South Africa1 site

  • Groote Schuur Hospital, Research ward

    Cape Town

Other trials in South Africa

About this study

Official title: Pharmacokinetic Interaction Between the Antimalarial Combination Artemether/Lumefantrine and Combination Antiretroviral Therapy Including Nevirapine in HIV-infected Adults

Despite the clinical significance of potential interactions between antimalarials and antiretrovirals, no drug interaction studies have been published and there is an urgent need to address this gap in current knowledge.

This study aims to assess the drug interaction between the antimalarial Artemether/Lumefantrine used for management of uncomplicated malaria and Nevirapine-based antiretroviral therapy.

Conditions
Malaria, HIV
Being tested
Artemether/Lumefantrine, Artemether/ lumefantrine
Keywords
malaria, HIV, AIDS, nevirapine, lumefantrine, artemether, drug interaction, pharmacokinetics
Medical subject headings
Malaria, Acquired Immunodeficiency Syndrome

What participants receive

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

  • Artemether/LumefantrineDrug

    Also called Coartem

    Coartem (fixed dose Artemether20mg /Lumefantrine 120mg) Dose: 4 tablets(80mg/480mg) twice daily for 3 days at 0,8,24,36,48 and 60 hours

  • Artemether/ lumefantrineDrug

    Also called Coartem

    Coartem (fixed dose Artemether20mg /Lumefantrine 120mg) Dose: 4 tablets(80mg/480mg) twice daily for 3 days at 0,8,24,36,48 and 60 hours

Study groups in NCT00790881
Study groupRoleWhat they receive
Antiretroviral-naiveOtherAntiretroviral-naive included as control group
Receives: Drug: Artemether/Lumefantrine
Nevirapine-based antiretroviral therapyActive comparatorNevirapine-based antiretroviral therapy
Receives: Drug: Artemether/ lumefantrine

What is being measured

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

  1. Lumefantrine plasma concentration

    Measured: day 7

Secondary outcomes (1)

  1. Point estimates and 90% confidence intervals for the mean ratios of the lumefantrine, artemether and DHA log-transformed Cmax, AUC0-t, AUC0 ∞ , t½,z, tmax and MRT with/without NVP

    Measured: 21 days

Timeline

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

  1. First posted14 Nov 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionAug 2009
  4. Study completionDec 2009

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
Treatment
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00790881
Sponsor's protocol ID
SEACAT 2.4.1
Other IDs
DOH-27-0807-2012
Status last verified
Jun 2010
First submitted
13 Nov 2008
Last updated
28 Jun 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Kredo T, Mauff K, Van der Walt JS, Wiesner L, Maartens G, Cohen K, Smith P, Barnes KI. Interaction between artemether-lumefantrine and nevirapine-based antiretroviral therapy in HIV-1-infected patients. Antimicrob Agents Chemother. 2011 Dec;55(12):5616-23. doi: 10.1128/AAC.05265-11. Epub 2011 Sep 26.

    PubMed 21947399

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Artemether/Lumefantrine and Artemether/ lumefantrine in people with Malaria and HIV, run by University of Cape Town at 1 site in South Africa.

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 7 inclusion and 26 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 28 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. 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?

Lumefantrine plasma concentration (time frame: day 7). 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 NCT00790881, 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 28 Jun 2010.

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