Pharmacokinetic Interaction Between the Antimalarial Combination Artemether/Lumefantrine and Combination Antiretroviral Therapy Including Lopinavir/Ritonavir in HIV-infected Adults (SEACAT 2_4_2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00869700
Recruitment Status : Completed
First Posted : March 26, 2009
Last Update Posted : June 28, 2010
London School of Hygiene and Tropical Medicine
Information provided by:
University of Cape Town

Brief 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.

The aim of the study is to investigate the pharmacokinetics (PK) of antimalarial combination artemether/lumefantrine (AL) and combination antiretroviral therapy (cART) including lopinavir/ritonavir (LPV/r) in HIV-infected adults.

Condition or disease Intervention/treatment Phase
HIV Infections Malaria Drug: Artemether/Lumefantrine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Interaction Between the Antimalarial Combination Artemether/Lumefantrine and Combination Antiretroviral Therapy Including Lopinavir/Ritonavir in HIV-infected Adults
Study Start Date : June 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Artemether/Lumefantrine

    80mg artemether/480mg lumefantrine

    Trade name: Coartem

    Indication: for management of non-severe malaria

Primary Outcome Measures :
  1. Lumefantrine concentration [ Time Frame: day 7 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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 of 18 years of age or older.
  • 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 15.2).
  • Karnofsky score above 70 (See Appendix 15.5).
  • CD4 count ≥ 200 cells/mm3
  • Patients on LPV/r-based cART at stable doses without significant toxicity for at least 6 weeks at screening.

Exclusion Criteria:

  • Patients diagnosed with malaria
  • Contraindications to artemether/lumefantrine:
  • Hypersensitivity to the artemether, lumefantrine or to any of the excipients of Coartem®.
  • 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.
  • 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) or CYP3A4.
  • 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.
  • Haemoglobin below 8.5g/dL for female and 9.5g/dL for male subjects.
  • 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 alcohol abuse.
  • The subject has consumed any alcohol, grapefruit or caffeine-containing products (ie tea, coffee, cola, chocolate) within 24 hours before any dose of AL during each PK profile.
  • The subject has participated in strenuous exercise within 24 hours before any AL dose.
  • 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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00869700

South Africa
Groote Schuur Hospital, Ward J51, Old Main Building
Cape Town, Western Province, South Africa, 7925
Sponsors and Collaborators
University of Cape Town
London School of Hygiene and Tropical Medicine
Principal Investigator: Karen I Barnes, MBChB MMed(clin pharm) University of Cape Town

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Professor Karen I Barnes, University of Cape Town Identifier: NCT00869700     History of Changes
Other Study ID Numbers: SEACAT 2_4_2
First Posted: March 26, 2009    Key Record Dates
Last Update Posted: June 28, 2010
Last Verified: June 2010

Keywords provided by University of Cape Town:
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Protozoan Infections
Parasitic Diseases
Artemether-lumefantrine combination
Anti-Retroviral Agents
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antiprotozoal Agents