Chronic Renal DiseaseLighTenNCT02381275
The Lighthouse Tenofovir Cohort Study
An observational study of Chronic Renal Disease, run by Lighthouse Trust at 1 site in Malawi.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Renal Disease
- What is being tested?
- Tenofovir Disoproxil Fumarate
- How many people
- 1,500 participants
- Where
- 1 siteMalawi
- Study dates
- 14 Aug 2014to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients initiating Tenofovir based ART regimen at the Lighthouse clinics
Who may be able to join
- 18 years or older
- Able and willing to give informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Chronic Renal Disease
- Being tested
- Tenofovir Disoproxil Fumarate
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir Disoproxil FumarateDrug
Observe long-term outcomes of patients using Tenofovir based antiretroviral therapy at the Lighthouse Clinics
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of HIV-infected individuals with renal dysfunction
Patients will be followed in the clinic up to 36 months
Measured: 36 months post ART initiation
Secondary outcomes (1)
Proportion of HIV-infected individuals with HIV/ HBV and HCV infections
Patients will be followed in the clinic up to 36 months
Measured: 36 months post ART initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study start14 Aug 2014
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lighthouse Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University, Ministry of Health, Malawi, University of Cologne
- Responsible party
- Principal investigator, Sam Phiri, PhD, MSc, DCM, Lighthouse Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381275
- Sponsor's protocol ID
- Lighten Cohort Study
- Acronym
- LighTen
- Status last verified
- Jun 2018
- First submitted
- 24 Feb 2015
- Last updated
- 7 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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 with HIV. AIDS. 2025 Nov 15;39(14):2059-2063. doi: 10.1097/QAD.0000000000004309. Epub 2025 Jul 23.
PubMed 40704988Steffen 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.
PubMed 37414923Kasper 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.
PubMed 34692392
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02381275
- Acronym / sponsor ID
- LighTen / Lighten Cohort Study
- Conditions
- Chronic Renal Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Lighthouse TrustUniversity, hospital or other
- Collaborators
- Heidelberg University, Ministry of Health, Malawi, University of Cologne
- Study start
- 14 Aug 2014 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 6 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients initiating Tenofovir based ART regimen at the Lighthouse clinics
Key inclusion criteria (2 listed)
- 18 years or older
- Able and willing to give informed consent
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir Disoproxil FumarateObserve long-term outcomes of patients using Tenofovir based antiretroviral therapy at the Lighthouse Clinics | Drug | – |
Primary outcome
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
1 secondary outcome
Proportion of HIV-infected individuals with HIV/ HBV and HCV infections
Time frame: 36 months post ART initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2018.
- Derived from this study: PubMed 40704988Steffen 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 with HIV. AIDS. 2025 Nov 15;39(14):2059-2063. doi: 10.1097/QAD.0000000000004309. Epub 2025 Jul 23.
- Derived from this study: PubMed 37414923Steffen 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.
- Derived from this study: PubMed 34692392Kasper 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Renal Disease, run by Lighthouse Trust at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of HIV-infected individuals with renal dysfunction (time frame: 36 months post ART initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02381275, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2018.