Last data update: Sep 23, 2024. (Total: 47723 publications since 2009)
Records 1-10 (of 10 Records) |
Query Trace: Angira F [original query] |
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Brief report: No differences between lopinavir/ritonavir and nonnucleoside reverse transcriptase inhibitor-based antiretroviral therapy on clearance of plasmodium falciparum subclinical parasitemia in adults living with HIV starting treatment (A5297)
Shaffer D , Kumwenda J , Chen H , Akelo V , Angira F , Kosgei J , Tonui R , Ssali F , McKhann A , Hogg E , Stewart VA , Murphy SC , Coombs R , Schooley R . J Acquir Immune Defic Syndr 2022 89 (2) 178-182 BACKGROUND: HIV protease inhibitors anti-Plasmodium falciparum activity in adults remains uncertain. METHODS: Adults with HIV CD4+ counts >200 cells/mm3 starting antiretroviral therapy (ART) with P. falciparum subclinical parasitemia (Pf SCP) were randomized 1:1 to (step 1) protease inhibitor lopinavir/ritonavir (LPV/r)-based (arm A) or nonnucleoside reverse transcriptase inhibitor (nNRTI)-based ART (arm B) for 15 days. In step 2, participants received nNRTI-based ART and trimethoprim/sulfamethoxazole prophylaxis for 15 days. P. falciparum SCP clearance was measured by polymerase chain reaction. The Fisher exact test [95% exact confidence interval (CI)] was used to compare proportions of P. falciparum SCP clearance (<10 parasites/L on 3 occasions within 24 hours) between LPV/r and nNRTI arms at day 15. The Kaplan-Meier method and log-rank test were used to compare time-to-clearance. RESULTS: Fifty-two adults from Kenya, Malawi, and Uganda with a median age = 31 (Q1, Q3: 24-39) years, 33% women, with baseline median CD4+ counts of 324 (259-404) cells/mm3, median HIV-1 RNA viremia of 5.18 log10 copies/mL (4.60-5.71), and median estimated P. falciparum density of 454 parasites/L (83-2219) enrolled in the study. Forty-nine (94%) participants completed the study. At day 15, there was no statistically significant difference in the proportions of P. falciparum SCP clearance between the LPV/r (23.1% clearance; 6 of the 26) and nNRTI (26.9% clearance; 7 of the 26) arms [between-arm difference 3.9% (95% CI, -21.1% to 28.4%; P = 1.00)]. No significant difference in time-to-clearance was observed between the arms (P = 0.80). CONCLUSIONS: In a small randomized study of adults starting ART with P. falciparum SCP, no statistically significant differences were seen between LPV/r- and nNRTI-based ART in P. falciparum SCP clearance after 15 days of treatment. |
CD4 lymphocyte enumeration and hemoglobin assessment aid for priority decisions: a multisite evaluation of the BD FACSPresto System
Thakar M , Angira F , Pattanapanyasat K , Wu AHB , O'Gorman M , Zeng H , Qu C , Mahajan B , Sukapirom K , Chen D , Hao Y , Gong Y , Indig MA , Graminske S , Orta D , d'Empaire N , Lu B , Omana-Zapata I , Zeh C . Open AIDS J 2017 11 76-90 Background: The BD FACSPresto system uses capillary and venous blood to measure CD4 absolute counts (CD4), %CD4 in lymphocytes, and hemoglobin (Hb) in approximately 25 minutes. CD4 cell count is used with portable CD4 counters in resource-limited settings to manage HIV/AIDS patients. A method comparison was performed using capillary and venous samples from seven clinical laboratories in five countries. The BD FACSPresto system was assessed for variability between laboratory, instrument/operators, cartridge lots and within-run at four sites. Methods: Samples were collected under approved voluntary consent. EDTA-anticoagulated venous samples were tested for CD4 and %CD4 T cells using the gold-standard BD FACSCalibur() system, and for Hb, using the Sysmex((R)) KX-21N() analyzer. Venous and capillary samples were tested on the BD FACSPresto system. Matched data was analyzed for bias (Deming linear regression and Bland-Altman methods), and for concordance around the clinical decision point. The coefficient of variation was estimated per site, instrument/operator, cartridge-lot and between-runs. Results: For method comparison, 93% of the 720 samples were from HIV-positive and 7% from HIV-negative or normal subjects. CD4 and %CD4 T cells venous and capillary results gave slopes within 0.96-1.05 and R(2) >/=0.96; Hb slopes were >/=1.00 and R(2) >/=0.89. Variability across sites/operators gave %CV <5.8% for CD4 counts, <1.9% for %CD4 and <3.2% for Hb. The total %CV was <7.7% across instrument/cartridge lot. Conclusion: The BD FACSPresto system provides accurate, reliable, precise CD4/%CD4/Hb results compared to gold-standard methods, irrespective of venous or capillary blood sampling. The data showed good agreement between the BD FACSPresto, BD FACSCalibur and Sysmex systems. |
Correlation of adherence by pill count, self-report, MEMS and plasma drug levels to treatment response among women receiving ARV therapy for PMTCT in Kenya
Mudhune V , Gvetadze R , Girde S , Ndivo R , Angira F , Zeh C , Thomas T , Lecher SL . AIDS Behav 2017 22 (3) 918-928 Success of antiretroviral therapy depends on adherence to effective treatment. We evaluated four adherence methods and their correlation with immunological and virologic response among women receiving PMTCT. Univariable and multivariable analyses were used to assess how adherence by pill count (n = 463), self-report (n = 463), MEMS (n = 129) and plasma drug level (n = 89) was associated with viral load suppression within a 6 months period. Longitudinal analysis was performed to determine the correlation of CD4 cell count with each measure of adherence. For all measures of adherence, sustained viral suppression was less likely for participants in the lowest category of adherence. Although CD4 cell count increased substantially over time, there was no significant association with adherence by the methods. Multiple strategies can be used successfully to monitor treatment adherence. Persons with ≥95% adherence by any method used in this study were more likely to have a favorable treatment outcome. |
Clinical evaluation of the BD FACSPresto Near-Patient CD4 Counter in Kenya
Angira F , Akoth B , Omolo P , Opollo V , Bornheimer S , Judge K , Tilahun H , Lu B , Omana-Zapata I , Zeh C . PLoS One 2016 11 (8) e0157939 BACKGROUND: The BD FACSPresto Near-Patient CD4 Counter was developed to expand HIV/AIDS management in resource-limited settings. It measures absolute CD4 counts (AbsCD4), percent CD4 (%CD4), and hemoglobin (Hb) from a single drop of capillary or venous blood in approximately 23 minutes, with throughput of 10 samples per hour. We assessed the performance of the BD FACSPresto system, evaluating accuracy, stability, linearity, precision, and reference intervals using capillary and venous blood at KEMRI/CDC HIV-research laboratory, Kisumu, Kenya, and precision and linearity at BD Biosciences, California, USA. METHODS: For accuracy, venous samples were tested using the BD FACSCalibur instrument with BD Tritest CD3/CD4/CD45 reagent, BD Trucount tubes, and BD Multiset software for AbsCD4 and %CD4, and the Sysmex KX-21N for Hb. Stability studies evaluated duration of staining (18-120-minute incubation), and effects of venous blood storage <6-24 hours post-draw. A normal cohort was tested for reference intervals. Precision covered multiple days, operators, and instruments. Linearity required mixing two pools of samples, to obtain evenly spaced concentrations for AbsCD4, total lymphocytes, and Hb. RESULTS: AbsCD4 and %CD4 venous/capillary (N = 189/ N = 162) accuracy results gave Deming regression slopes within 0.97-1.03 and R2 ≥0.96. For Hb, Deming regression results were R2 ≥0.94 and slope ≥0.94 for both venous and capillary samples. Stability varied within 10% 2 hours after staining and for venous blood stored less than 24 hours. Reference intervals results showed that gender-but not age-differences were statistically significant (p<0.05). Precision results had <3.5% coefficient of variation for AbsCD4, %CD4, and Hb, except for low AbsCD4 samples (<6.8%). Linearity was 42-4,897 cells/muL for AbsCD4, 182-11,704 cells/muL for total lymphocytes, and 2-24 g/dL for Hb. CONCLUSIONS: The BD FACSPresto system provides accurate, precise clinical results for capillary or venous blood samples and is suitable for near-patient CD4 testing. TRIAL REGISTRATION: ClinicalTrials.gov NCT02396355. |
Anaemia in HIV-infected pregnant women receiving triple antiretroviral combination therapy for prevention of mother-to-child transmission: a secondary analysis of the Kisumu breastfeeding study (KiBS)
Odhiambo C , Zeh C , Angira F , Opollo V , Akinyi B , Masaba R , Williamson JM , Otieno J , Mills LA , Lecher SL , Thomas TK . Trop Med Int Health 2016 21 (3) 373-84 OBJECTIVE: The prevalence of anaemia during pregnancy is estimated to be 35-75% in sub-Saharan Africa and is associated with an increased risk of maternal mortality. We evaluated the frequency and factors associated with anaemia in HIV-infected women undergoing antiretroviral (ARV) therapy for prevention of mother-to-child transmission (PMTCT) enrolled in The Kisumu Breastfeeding Study 2003-2009. METHODS: Maternal haematological parameters were monitored from 32 to 34 weeks of gestation to 2 years post-delivery among 522 enrolled women. Clinical and laboratory assessments for causes of anaemia were performed, and appropriate management was initiated. Anaemia was graded using the National Institutes of Health Division of AIDS 1994 Adult Toxicity Tables. Data were analysed using SAS software, v 9.2. The Wilcoxon two-sample rank test was used to compare groups. A logistic regression model was fitted to describe the trend in anaemia over time. RESULTS: At enrolment, the prevalence of any grade anaemia (Hb < 9.4 g/dl) was 61.8%, but fell during ARV therapy, reaching a nadir (7.4%) by 6 months post-partum. A total of 41 women (8%) developed severe anaemia (Hb < 7 g/dl) during follow-up; 2 (4.9%) were hospitalised for blood transfusion, whereas 3 (7.3%) were transfused while hospitalised (for delivery). The greatest proportion of severe anaemia events occurred around delivery (48.8%; n = 20). Anaemia (Hb ≥ 7 and < 9.4 g/dl) at enrolment was associated with severe anaemia at delivery (OR 5.87; 95% CI: 4.48, 7.68, P < 0.01). Few cases of severe anaemia coincided with clinical malaria (24.4%; n = 10) and helminth (7.3%; n = 3) infections. CONCLUSION: Resolution of anaemia among most participants during study follow-up was likely related to receipt of ARV therapy. Efforts should be geared towards addressing common causes of anaemia in HIV-infected pregnant women, prioritising initiation of ARV therapy and management of peripartum blood loss. |
Disseminating results: community response and input on Kisumu breastfeeding study
Ondenge K , McLellan-Lemal E , Awuonda E , Angira F , Mills LA , Thomas T . Transl Behav Med 2015 5 (2) 207-15 Communicating findings to study participants and their communities is a practice that often gets overlooked or receives low prioritization by research investigators, but is crucially important. The purpose of this study was to describe the process and community response to the dissemination of results from the Kisumu Breastfeeding Study (KiBS), specifically in terms of (1) community research knowledge and expectations and (2) impressions of result dissemination efforts. A qualitative evaluation was completed for 10 result dissemination events using focus group discussions (FGDs) (n = 10; total number of participants = 98). An inductive, thematic qualitative data analysis was completed in NVivo 8.0. Overall, FGD participants expressed great appreciation for being given information on the study results. Participants had a good understanding of what research entails and had specific expectations for the process, including that the community receive information about the study, not only at the end of the study but also at regular intervals throughout the study's conduct. They also wanted to receive the communications from a credible source, the principal investigator preferably. Other expectations centered on better community and research interactions and development and the use of community collaborators. Impressions of KiBS result dissemination events were positive, but suggestions for the future included having the event in a larger area, inviting more people, having more written materials, and putting the information in an entertaining format such as skits or movies. Sharing study findings with local community members is essential and beneficial to the researchers' long-term engagement with communities and importantly, the successful implementation of study findings when appropriate. It is imperative that dissemination of results be embedded as an integral part of research project planning and development. |
Outcomes in a cohort of women who discontinued maternal triple-antiretroviral regimens initially used to prevent mother-to-child transmission during pregnancy and breastfeeding-Kenya, 2003-2009
Minniear TD , Girde S , Angira F , Mills LA , Zeh C , Peters PJ , Masaba R , Lando R , Thomas TK , Taylor AW . PLoS One 2014 9 (4) e93556 BACKGROUND: In 2012, the World Health Organization (WHO) amended their 2010 guidelines for women receiving limited duration, triple-antiretroviral drug regimens during pregnancy and breastfeeding for prevention of mother-to-child transmission of HIV (tARV-PMTCT) (Option B) to include the option to continue lifelong combination antiretroviral therapy (cART) (Option B+). We evaluated clinical and CD4 outcomes in women who had received antiretrovirals for prevention of mother-to-child transmission and then discontinued antiretrovirals 6-months postpartum. METHODS AND FINDINGS: The Kisumu Breastfeeding Study, 2003-2009, was a prospective, non-randomized, open-label clinical trial of tARV-PMTCT in ARV-naive, Kenyan women. Women received tARV-PMTCT from 34 weeks' gestation until 6-months postpartum when women were instructed to discontinue breastfeeding. Women with CD4 count (CD4) <250cells/mm3 or WHO stage III/IV prior to 6-months postpartum continued cART indefinitely. We estimated the change in CD4 after discontinuing tARV-PMTCT and the adjusted relative risk [aRR] for factors associated with declines in maternal CD4. We compared maternal and infant outcomes following weaning-when tARV-PMTCT discontinued-by maternal ARV status through 24-months postpartum. Compared with women who continued cART, discontinuing antiretrovirals was associated with infant HIV transmission and death (10.1% vs. 2.4%; P = 0.03). Among women who discontinued antiretrovirals, CD4<500 cells/mm3 at either initiation (21.8% vs. 1.5%; P = 0.002; aRR: 9.8; 95%-confidence interval [CI]: 2.4-40.6) or discontinuation (36.9% vs. 8.3%; P<0.0001; aRR: 4.4; 95%-CI: 1.9-5.0) were each associated with increased risk of women requiring cART for their own health within 6 months after discontinuing. CONCLUSIONS: Considering the serious health risks to the woman's infant and the brief reprieve from cART gained by stopping, every country should evaluate the need for and feasibility to implement WHO Option B+ for PMTCT. Evaluating CD4 at antiretroviral initiation or 6-months postpartum can identify pregnant women who would most benefit from continuing cART in settings unable to implement WHO Option B+. |
Rash, hepatotoxicity and hyperbilirubinemia among Kenyan infants born to HIV-infected women receiving triple-antiretroviral drugs for the prevention of mother-to-child HIV transmission
Minniear TD , Zeh C , Polle N , Masaba R , Peters PJ , Oyaro B , Akoth B , Ndivo R , Angira F , Mills LA , Thomas TK . Pediatr Infect Dis J 2012 31 (11) 1155-7 We compared adverse events among breastfeeding neonates born to Kenyan mothers receiving triple-antiretroviral therapy including either nevirapine or nelfinavir. Nevirapine-exposed infants had an absolute increase in risk for rash but no significant risk differences for hepatotoxicity or high-risk hyperbilirubinemia compared with nelfinavir-exposed infants. From an infant-safety perspective, nevirapine-based regimens given during pregnancy and breastfeeding are viable options where alternatives to breast milk are not safe, affordable, or feasible. |
Nevirapine-associated hepatotoxicity and rash among HIV-infected pregnant women in Kenya
Peters PJ , Polle N , Zeh C , Masaba R , Borkowf CB , Oyaro B , Omolo P , Ogindo P , Ndivo R , Angira F , Lando R , Fowler MG , Weidle PJ , Thomas TK . J Int Assoc Physicians AIDS Care (Chic) 2012 11 (2) 142-9 BACKGROUND: Few studies have evaluated the risk of nevirapine (NVP)-associated hepatotoxicity among HIV-infected pregnant women with a CD4 count ≥250 cells/mm(3). METHODS: We enrolled HIV-infected pregnant Kenyan women who initiated triple antiretroviral therapy (ART) at 34 weeks gestation. We compared the rates of severe hepatotoxicity (grades 3-4 hepatotoxicity) and rash-associated hepatotoxicity (rash with ≥grade 2 hepatotoxicity) with NVP and nelfinavir (NFV), respectively. RESULTS: We initiated triple ART in 522 pregnant women; severe hepatotoxicity and rash-associated hepatotoxicity occurred in 14 (3%) and 9 (2%) women, respectively. Women who initiated NVP had higher rates of severe hepatotoxicity (5% vs 1%; P = .03) and rash-associated hepatotoxicity (4% vs 0%; P = .003) when compared with NFV. Among women who initiated NVP (n = 254), a baseline CD4 count ≥250 cells/mm(3) was not associated with severe hepatotoxicity (5% vs 3%; P = .52) or rash-associated hepatotoxicity (4% vs 3%; P = .69). CONCLUSION: Nevirapine use but not CD4 count ≥250 cells/mm(3) was associated with hepatotoxicity. |
Nelfinavir and its active metabolite, hydroxyl-t-butylamidenelfinavir (M8), are transferred in low quantities to breast milk and do not result in biologically significant concentrations in breast-feeding infants whose mothers are taking nelfinavir
Weidle PJ , Zeh C , Martin A , Lando R , Angira F , Osoga J , Ogindo P , Girde S , Minniear TD , Thomas TK . Antimicrob Agents Chemother 2011 55 (11) 5168-71 Antiretroviral drugs cross from maternal plasma to breast milk and from breast milk to the infant in different concentrations. We measured concentrations of nelfinavir and its active metabolite (M8) in maternal plasma and breast milk from women and in dried blood spots collected from their infants at delivery and postnatal weeks 2, 6, 14, and 24 in the Kisumu Breastfeeding Study, Kisumu, Kenya. Nelfinavir-based antiretroviral regimens given to mothers as PMTCT do not expose the breastfeeding infant to biologically significant concentrations of nelfinavir or M8. |
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