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The Lighthouse Tenofovir Cohort Study (LighTen)

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.
 
ClinicalTrials.gov Identifier: NCT02381275
Recruitment Status : Active, not recruiting
First Posted : March 6, 2015
Last Update Posted : June 7, 2018
Sponsor:
Collaborators:
Heidelberg University
Ministry of Health, Malawi
University of Cologne
Information provided by (Responsible Party):
Sam Phiri, PhD, MSc, DCM, Lighthouse Trust

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Chronic Renal Disease Drug: Tenofovir Disoproxil Fumarate

Detailed Description:

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.

Study Design
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Study Type : Observational
Actual Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Baseline Characteristics and Long Term Clinical Outcomes of Patients Using Malawi's New First Line Antiretroviral Regimen at Lighthouse: The Lighthouse Tenofovir Cohort
Actual Study Start Date : August 14, 2014
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Drug: Tenofovir Disoproxil Fumarate
    Observe long-term outcomes of patients using Tenofovir based antiretroviral therapy at the Lighthouse Clinics

Outcome Measures
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Primary Outcome Measures :
  1. Proportion of HIV-infected individuals with renal dysfunction [ Time Frame: 36 months post ART initiation ]
    Patients will be followed in the clinic up to 36 months


Secondary Outcome Measures :
  1. Proportion of HIV-infected individuals with HIV/ HBV and HCV infections [ Time Frame: 36 months post ART initiation ]
    Patients will be followed in the clinic up to 36 months


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients initiating Tenofovir based ART regimen at the Lighthouse clinics
Criteria

Inclusion Criteria:

  • 18 years or older
  • Able and willing to give informed consent
Contacts and Locations
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Information from the National Library of Medicine

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 ClinicalTrials.gov identifier (NCT number): NCT02381275


Locations
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Malawi
Lighthouse Clinic
Lilongwe, Malawi, 0000
Sponsors and Collaborators
Lighthouse Trust
Heidelberg University
Ministry of Health, Malawi
University of Cologne
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Responsible Party: Sam Phiri, PhD, MSc, DCM, Executive Director, Lighthouse Trust
ClinicalTrials.gov Identifier: NCT02381275    
Other Study ID Numbers: Lighten Cohort Study
First Posted: March 6, 2015    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Renal Insufficiency, Chronic
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency
Tenofovir
Antiviral Agents
 Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents