Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1500 participants
OBSERVATIONAL
2014-08-14
2018-07-31
Brief Summary
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The results will be disseminated both nationally at the Ministry of Health Technical Working Group (TWG), at the annual Research Dissemination and Best Practices conferences of the College of Medicine and National AIDS Commission as well as internationally. The results will also be written up for publication in appropriate peer-reviewed journals.
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Detailed Description
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The aim of this study is to describe baseline clinical characteristics and long-term outcomes of patients using Tenofovir based antiretroviral therapy at the Lighthouse Clinics. The specific objectives are outlined below:
Objective 1: To determine the prevalence of renal dysfunction at enrolment and during follow-up among adult HIV-infected individuals starting ART.
Objective 2: To determine the prevalence of Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) infections among adult HIV-infected individuals starting ART and during treatment follow-up.
Objective 3: To determine the prevalence of non-communicable co-morbidities during treatment follow-up of HIV-infected individuals starting ARTand during treatment follow-up.
The study will take place at the Lighthouse, a tertiary referral ART centre, with over 25,000 patients, in Lilongwe, Malawi. Considering the study cost and power to detect a prevalence of 22% for renal impairment, we expect to have a convenience sample size of at least 850 patients at the end of three year follow-up period. The current retention at three years is almost 56%. Using this retention, we will therefore enrol almost 1,500 patients starting ART.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Tenofovir Disoproxil Fumarate
Observe long-term outcomes of patients using Tenofovir based antiretroviral therapy at the Lighthouse Clinics
Eligibility Criteria
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Inclusion Criteria
* Able and willing to give informed consent
18 Years
ALL
No
Sponsors
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Heidelberg University
OTHER
Ministry of Health, Malawi
OTHER_GOV
University of Cologne
OTHER
Lighthouse Trust
OTHER
Responsible Party
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Sam Phiri, PhD, MSc, DCM
Executive Director
Locations
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Lighthouse Clinic
Lilongwe, , Malawi
Countries
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References
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Steffen HM, Viola E, Thawani A, Kachere LG, Huwa J, Wallrauch C, Kasper P, Neuhann F, Heller T, Winkler V, Rambiki E, Mahanani MR. Blood pressure, weight change and incident hypertension after switching to dolutegravir in treatment-experienced people living with HIV. AIDS. 2025 Jul 24. doi: 10.1097/QAD.0000000000004309. Online ahead of print.
Steffen HM, Mahanani MR, Neuhann F, Nhlema A, Kasper P, de Forest A, Chaweza T, Tweya H, Heller T, Chiwoko J, Winkler V, Phiri S. Blood pressure changes during tenofovir-based antiretroviral therapy among people living with HIV in Lilongwe, Malawi: results from the prospective LighTen Cohort Study. Clin Res Cardiol. 2023 Nov;112(11):1650-1663. doi: 10.1007/s00392-023-02253-w. Epub 2023 Jul 6.
Kasper P, Nhlema A, de Forest A, Tweya H, Chaweza T, Mwagomba BM, Mula AM, Chiwoko J, Neuhann F, Phiri S, Steffen HM. 24-h-Ambulatory Blood Pressure Monitoring in Sub-Saharan Africa: Hypertension Phenotypes and Dipping Patterns in Malawian HIV+ Patients on Antiretroviral Therapy. Glob Heart. 2021 Oct 13;16(1):67. doi: 10.5334/gh.945. eCollection 2021.
Other Identifiers
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Lighten Cohort Study
Identifier Type: -
Identifier Source: org_study_id
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