Clinical trial · Observational
Liver Fibrosis in Zambian HIV-HBV Co-infected Patients
Liver Fibrosis in Zambian HIV-HBV Co-infected Patients: a Long-term Prospective Cohort Study
NCT02344680CI-TRIAL-00116613completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A cohort of adults with HIV-HBV co-infection will be created in Lusaka, Zambia, to describe the short and long-term (up to 10 years of follow-up) HBV and liver outcomes, including the effectiveness of current therapies, and to identify the risk factors for major endpoints of interest, including HCC and HBV functional cure. This cohort will also create a pool of potential participants for in-depth mechanistic studies and clinical trials of novel HBV cure drugs.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alcoholic Hepatitis | — | UNRESOLVED | — |
| Cirrhosis, Liver | — | UNRESOLVED | — |
| Fibrosis, Liver | — | UNRESOLVED | — |
| HBV | — | UNRESOLVED | — |
| Hepatitis Delta Virus | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Human Immunodeficiency Virus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-HIV Agents | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Adults with HIV-HBV co-infection
- description
- Adults with HIV-HBV co-infection who are receiving antiretroviral therapy
- interventionNames
- Drug: Anti-HIV Agents
Primary outcomes (1)
- measure
- Reduction in Liver Fibrosis Stage
- timeFrame
- From baseline to 10 years of follow-up
- description
- Based on transient elastography, we calculated the number and proportion of participants with at least significant fibrosis at their first measure who regressed to minimal-no fibrosis during follow-up. This outcome excluded participants with no-minimal fibrosis at enrollment.
Secondary outcomes (3)
- measure
- Prevalence of Significant Liver Fibrosis (Metavir F2 or Greater)
- timeFrame
- At enrollment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older * Living with HIV infection * Living with active HBV infection, defined as any single positive HBsAg assay * Naïve to antiretroviral therapy or currently participating in HIV/HBV co-infection in IeDEA-SA Exclusion Criteria: * Unable or unwilling to provide informed consent * Planning to relocate out of Lusaka district
References
Publications (36)
- BACKGROUNDWeber R, Sabin CA, Friis-Moller N, Reiss P, El-Sadr WM, Kirk O, Dabis F, Law MG, Pradier C, De Wit S, Akerlund B, Calvo G, Monforte Ad, Rickenbach M, Ledergerber B, Phillips AN, Lundgren JD. Liver-related deaths in persons infected with the human immunodeficiency virus: the D:A:D study. Arch Intern Med. 2006 Aug 14-28;166(15):1632-41. doi: 10.1001/archinte.166.15.1632. PMID 16908797
- BACKGROUNDCentral Statistical Office (CSO) MoH, Tropical Diseases Research Centre, University of Zambia, and Macro International Inc. Zambia Demographic and Health Survey 2007. Calverton, Maryland, USA: CSO and Macro International Inc., 2009.
- BACKGROUNDKapembwa KC, Goldman JD, Lakhi S, Banda Y, Bowa K, Vermund SH, Mulenga J, Chama D, Chi BH. HIV, Hepatitis B, and Hepatitis C in Zambia. J Glob Infect Dis. 2011 Jul;3(3):269-74. doi: 10.4103/0974-777X.83534. PMID 21887060
- BACKGROUNDHamers RL, Zaaijer HL, Wallis CL, Siwale M, Ive P, Botes ME, Sigaloff KC, Hoepelman AI, Stevens WS, Rinke de Wit TF; PharmAccess African Studies to Evaluate Resistance (PASER). HIV-HBV coinfection in Southern Africa and the effect of lamivudine- versus tenofovir-containing cART on HBV outcomes. J Acquir Immune Defic Syndr. 2013 Oct 1;64(2):174-82. doi: 10.1097/QAI.0b013e3182a60f7d. PMID 23892239
- BACKGROUNDMartin-Carbonero L, Teixeira T, Poveda E, Plaza Z, Vispo E, Gonzalez-Lahoz J, Soriano V. Clinical and virological outcomes in HIV-infected patients with chronic hepatitis B on long-term nucleos(t)ide analogues. AIDS. 2011 Jan 2;25(1):73-9. doi: 10.1097/QAD.0b013e328340fde2. PMID 21076274
- BACKGROUNDTuma P, Medrano J, Resino S, Vispo E, Madejon A, Sanchez-Piedra C, Rivas P, Labarga P, Martin-Carbonero L, Barreiro P, Soriano V. Incidence of liver cirrhosis in HIV-infected patients with chronic hepatitis B or C in the era of highly active antiretroviral therapy. Antivir Ther. 2010;15(6):881-6. doi: 10.3851/IMP1630. PMID 20834100