The Lighthouse Tenofovir Cohort Study

Study Overview
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Brief Summary
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Lighthouse, in cooperation with the University Heidelberg Public Health Institute and the University Köln (Cologne) would like to set up a cohort to study baseline characteristics and long-term clinical outcomes of patients using Tenofovir based Antiretroviral Therapy at the Lighthouse. As of March 2014, patients above 18 years and giving informed consent coming to the Lighthouse to newly initiate ART will be approached to enroll in the cohort. 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.

Detailed Description
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The proposed observational cohort study will lead to improved identification of patients with virological failure and adverse drug effects, improved identification of relevant co-morbidities and result in better individual management. More importantly however, the results will allow estimates for the proportion of the described complications in the overall Malawian treatment cohort. This claim can be exemplified by the retrospective analysis of patients at the Lighthouse who were switched from the new 5A regimen to 6 A regimen as a result of adverse effects of Efavirenz. 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.

Official Title
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Baseline Characteristics and Long Term Clinical Outcomes of Patients Using Malawi's New First Line Antiretroviral Regimen at Lighthouse: The Lighthouse Tenofovir Cohort

Conditions
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Chronic Renal Disease

Intervention / Treatment
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* Drug: Tenofovir Disoproxil Fumarate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Able and willing to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tenofovir Disoproxil Fumarate|Observe long-term outcomes of patients using Tenofovir based antiretroviral therapy at the Lighthouse Clinics|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of HIV-infected individuals with renal dysfunction | Patients will be followed in the clinic up to 36 months | 36 months post ART initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of HIV-infected individuals with HIV/ HBV and HCV infections | Patients will be followed in the clinic up to 36 months | 36 months post ART initiation |