Status:
COMPLETED
Dolutegravir Interactions With Artemisinin-based Combination Therapies
Lead Sponsor:
University of Liverpool
Collaborating Sponsors:
ViiV Healthcare
Makerere University
Conditions:
Malaria
HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Malaria and HIV are found in the same regions of the world and developing countries are most affected by both diseases. For malaria, new drugs have been introduced called ACTs. These drugs are effecti...
Detailed Description
More than 90% of the malaria occurs in sub-Saharan Africa (WHO 2008), the region bearing 67% of the global HIV burden (WHO 2011). Given the extensive overlap in geographical distribution of these dise...
Eligibility Criteria
Inclusion
- Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.
- Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Men and women aged 18 years and above
- Weight ≥40 kg
- HIV antibody negative at screening.
- Malaria blood film negative at screening
- Willing to use mosquito bednets routinely for the duration of the study
- Women of childbearing potential must be willing to use an effective barrier contraception method for the duration of the study.
Exclusion
- Significant disease affecting cardiac, respiratory, gastrointestinal or neurological symptoms which in the clinician's medical judgment could be worsened by participating in this study or the presence of medical or surgical conditions which could prevent the subject from complying with study procedures.
- Serum alanine transaminase (ALT) levels above 3x upper limit of normal
- Serum creatinine levels above 2x upper limit of normal
- Hepatitis B surface antigen positive
- Use of medications which are known inducers/inhibitors of CYP or glucuronyl transferase UGT1A1 within past 2 months (e.g. anticonvulsants, TB medications, HIV agents for prophylaxis, azole antifungals)
- Evidence of QT prolongation on electrocardiogram (ECG) QTc (Rate adjusted QT interval) \>450ms (men) or \>470ms (women)
- Pregnant women or female subjects who are unwilling to use a suitable contraceptive method for the duration of the study (condom, diaphragm, IUD or contraceptive implant)
- Likely to be poorly adherent based on clinician's medical judgement
- Known to be current injection drug user
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT02242799
Start Date
June 1 2015
End Date
September 1 2016
Last Update
October 5 2016
Active Locations (1)
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1
Infectious Diseases Institute
Kampala, Uganda