As-Needed Vs Immediate Etoposide Chemotherapy in Combination With Antiretroviral Therapy for Mild-to-Moderate AIDS-Associated Kaposi Sarcoma in Resource-Limited Settings: A5264/AMC-067 Randomized Clinical Trial

Hosseinipour, Mina C.; Kang, Min-Hee; Krown, Susan E.; Bukuru, Aggrey; Umbleja, Triin; Martin, Jeffrey N.; Orem, Jackson; Godfrey, Catherine; Hoagland, Brenda; Mwelase, Noluthando; Langat, Deborah; Nyirenda, Mulinda; MacRae, John D.; Borok, Margaret; Samaneka, Wadzanai; Moses, Agnes; Mngqbisa, Rosie; Busakhala, Naftali; Martı́nez-Maza, Otoniel; Ambinder, Richard F.; Dittmer, Dirk P.; Nokta, Mostafa; Campbell, Thomas; Team, Amc React-Ks

doi:10.1093/cid/ciy044

Cited by 28 publications

(50 citation statements)

References 32 publications

(31 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The first (ClinicalTrials.gov identifier: NCT01352117 ) was a prospective, randomized, phase III trial to evaluate the role of early versus delayed oral etoposide in people with mild-to-moderate KS who were initiating ART. 18 The study enrolled 192 participants—93% from SSA—and although the primary outcome did not differ between arms, time to KS progression ( P = .021), KS immune response inflammatory syndrome ( P = .003), and KS response ( P = .003) favored the early chemotherapy arm. Additional analyses of associations between early chemotherapy and KS immune response inflammatory syndrome and early KS progression are ongoing, 19 as are studies of baseline prevalence of KSHV inflammatory cytokine syndrome among enrolled participants.…”

Section: Hivam Trials In Ssamentioning

confidence: 99%

Clinical Trials for Treatment and Prevention of HIV-Associated Malignancies in Sub-Saharan Africa: Building Capacity and Overcoming Barriers

Lin

Lakomy

Chiao

et al. 2020

JCO Global Oncology

Self Cite

View full text Add to dashboard Cite

PURPOSE The aim of this study was to review the current status of clinical trials for HIV-associated malignancies in people living with HIV in sub-Saharan Africa (SSA) and efforts made by the AIDS Malignancy Consortium (AMC) to build capacity in SSA for HIV malignancy research. METHODS All malignancy-related clinical trials in 49 SSA countries on ClinicalTrials.gov were reviewed and evaluated for inclusion and exclusion criteria pertaining to HIV status. Additional studies by AMC in SSA were compiled from Web-based resources, and narrative summaries were prepared to highlight AMC capacity building and training initiatives. RESULTS Of 96 cancer trials identified in SSA, only 11 focused specifically on people living with HIV, including studies in Kaposi sarcoma, cervical dysplasia and cancer, non-Hodgkin lymphoma, and ocular surface squamous neoplasia. Recognizing the increasing cancer burden in the region, AMC expanded its clinical trial activities to SSA in 2010, with 4 trials completed to date and 6 others in progress or development, and has made ongoing investments in developing research infrastructure in the region. CONCLUSION As the HIV-associated malignancy burden in SSA evolves, research into this domain has been limited. AMC, the only global HIV malignancy-focused research consortium, not only conducts vital HIV-associated malignancies research in SSA, but also develops pathology, personnel, and community-based infrastructure to meet these challenges in SSA. Nonetheless, there is an ongoing need to build on these efforts to improve HIV-associated malignancies outcomes in SSA.

show abstract

Section: Hivam Trials In Ssamentioning

confidence: 99%

Clinical Trials for Treatment and Prevention of HIV-Associated Malignancies in Sub-Saharan Africa: Building Capacity and Overcoming Barriers

Lin

Lakomy

Chiao

et al. 2020

JCO Global Oncology

Self Cite

View full text Add to dashboard Cite

show abstract

“…However, the question remains which signs or symptoms of KS are predictive of KS mortality. In addition to TIS staging predictors, previous studies from both high and low income settings have found that pulmonary involvement, 11 woody edema, 22 low BMI, 26 low hemoglobin, 26 low albumin, 25 older age, 23 decreased performance status, 23,25 and positive HHV-8 DNA to be predictive of mortality. 6,27 The linkage of staging criteria with outcomes has recently been performed in the pediatric KS literature in Malawi, but has not yet been performed for the adult KS population in sub-Saharan Africa during the treat-all era.…”

Section: Ks Staging At Time Of Diagnosismentioning

confidence: 99%

Beyond T Staging in the Treat All Era: Capturing the Severity and Heterogeneity of Kaposi’s Sarcoma in East Africa

Freeman

McMahon

Semeere

et al. 2020

Preprint

Self Cite

View full text Add to dashboard Cite

Background: In the treat-all era of HIV, Kaposi's sarcoma (KS) remains one of the most incident cancers in sub-Saharan Africa. The majority of patients with KS are diagnosed at advanced disease stage in this setting. Staging systems for KS, specifically the AIDS Clinical Trials Group (ACTG) system, were developed in the pre-ART era, were not meant to guide treatment, and may not fully capture the clinical heterogeneity of advanced disease. There is no international consensus on which KS patients need chemotherapy in addition to antiretroviral therapy (ART). Understanding KS severity of disease in the current era would help to inform prognosis and clarify treatment guidelines. Methods: We performed rapid case ascertainment (RCA) on people living with HIV ≥18 years old newly diagnosed with biopsy-proven KS from 2016 to 2019 at three clinic sites in Kenya and Uganda. As close as possible to time of diagnosis, we performed a structured interview, physical examination, and collection of laboratory specimens. We reported KS severity using ACTG and WHO staging criteria, as well as detailed measurements not captured in current staging systems. Results: We enrolled 264 adults newly diagnosed with KS. RCA was performed within 1 month of KS diagnosis for 62% of patients and within 6 months for 73% of patients. Patients were 61% Kenyan, 69% male, and with a median age of 35. Median CD4 count was 239 (IQR 87 to 408), with 72% of patients initiating ART greater than 60 days prior to diagnosis. The majority of patients had advanced stage of disease, with 82% qualifying as ACTG T1 and 64% as WHO Severe/Symptomatic KS. There was marked heterogeneity within advanced KS, with 25% of patients having two ACTG qualifiers and 3% of patients had three or more ACTG qualifiers. Conclusion: The majority of patients with KS in this study had advanced stage disease at time of diagnosis, highlighting the need to improve early diagnosis of KS. Within this group of advanced stage patients was large clinical heterogeneity, leading to questions about whether all patients with advanced KS require the same treatment strategy.

show abstract

“…Upon initiation of cART, KS can also progress, possibly triggered by, or exacerbated by a KS immune reconstitution inflammatory syndrome (IRIS) [10]. AIDS-KS continues to have a high mortality rate in sub-Saharan Africa [11] and is still associated with morbidity and mortality in the US among HIV-infected patients [12].…”

Section: Introductionmentioning

confidence: 99%

Signatures of oral microbiome in HIV-infected individuals with oral Kaposi's sarcoma and cell-associated KSHV DNA

et al. 2020

View full text Add to dashboard Cite

Infection by Kaposi's sarcoma-associated herpesvirus (KSHV) is necessary for the development of Kaposi's sarcoma (KS), which most often develops in HIV-infected individuals. KS frequently has oral manifestations and KSHV DNA can be detected in oral cells. Numerous types of cancer are associated with the alteration of microbiome including bacteria and virus. We hypothesize that oral bacterial microbiota affects or is affected by oral KS and the presence of oral cell-associated KSHV DNA. In this study, oral and blood specimens were collected from a cohort of HIV/KSHV-coinfected individuals all previously diagnosed with KS, and were classified as having oral KS with any oral cell-associated KSHV DNA status (O-KS, n = 9), no oral KS but with oral cell-associated KSHV DNA (O-KSHV, n = 10), or with neither oral KS nor oral cell-associated KSHV DNA (No KSHV, n = 10). We sequenced the hypervariable V1-V2 region of the 16S rRNA gene present in oral cell-associated DNA by next generation sequencing. The diversity, richness, relative abundance of operational taxonomic units (OTUs) and taxonomic composition of oral microbiota were analyzed and compared across the 3 studied groups. We found impoverishment of oral microbial diversity and enrichment of specific microbiota in O-KS individuals compared to O-KSHV or No KSHV individuals. These results suggest that HIV/KSHV coinfection and oral microbiota might impact one another and influence the development of oral KS.

show abstract

As-Needed Vs Immediate Etoposide Chemotherapy in Combination With Antiretroviral Therapy for Mild-to-Moderate AIDS-Associated Kaposi Sarcoma in Resource-Limited Settings: A5264/AMC-067 Randomized Clinical Trial

Abstract: NCT01352117.

Cited by 28 publications

References 32 publications

Clinical Trials for Treatment and Prevention of HIV-Associated Malignancies in Sub-Saharan Africa: Building Capacity and Overcoming Barriers

Clinical Trials for Treatment and Prevention of HIV-Associated Malignancies in Sub-Saharan Africa: Building Capacity and Overcoming Barriers

Beyond T Staging in the Treat All Era: Capturing the Severity and Heterogeneity of Kaposi’s Sarcoma in East Africa

Signatures of oral microbiome in HIV-infected individuals with oral Kaposi's sarcoma and cell-associated KSHV DNA

Contact Info

Product

Resources

About