NCT02381275

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 14, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 6, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

June 7, 2018

Status Verified

June 1, 2018

Enrollment Period

3.9 years

First QC Date

February 24, 2015

Last Update Submit

June 6, 2018

Conditions

Chronic Renal Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Proportion of HIV-infected individuals with HIV/ HBV and HCV infections

    36 months post ART initiation

Interventions

Tenofovir Disoproxil FumarateDRUG

Observe long-term outcomes of patients using Tenofovir based antiretroviral therapy at the Lighthouse Clinics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients initiating Tenofovir based ART regimen at the Lighthouse clinics

You may qualify if:

  • years or older
  • Able and willing to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lighthouse Clinic

Lilongwe, 0000, Malawi

Location

Related Publications (3)

  • 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.

    PMID: 40704988DERIVED

  • 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.

    PMID: 37414923DERIVED

  • 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.

    PMID: 34692392DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Director

Study Record Dates

First Submitted

February 24, 2015

First Posted

March 6, 2015

Study Start

August 14, 2014

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

June 7, 2018

Record last verified: 2018-06

Locations

MA(1)