Browsing by Author "Kyeyune, Rachel"

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    The effect of standard dose multivitamin supplementation on disease progression in HIV infected adults initiating HAART: a randomized double blind placebo-controlled trial in Uganda
    (BMC infectious diseases, 2015) Guwatudde, David; Wang, Molin; Ezeamama, Amara E.; Bagenda, Danstan; Kyeyune, Rachel; Wamani, Henry; Manabe, Yukari C.; Fawzi, Wafaie W.
    Efficacy trials investigating the effect of multivitamin (MV) supplementations among patients on Highly Active Antiretroviral Therapy (HAART) have so far been inconclusive. We conducted a randomized, double blind, placebo controlled trial to determine the effect of one recommended daily allowance (RDA) of MV supplementation on disease progression in patients initiating HAART. Methods: Eligible subjects were randomized to receive placebo or MV supplementation including vitamins Bcomplex, C and E. Participants were followed for up to 18 months. Primary endpoints were: change in CD4 cell count, weight and quality of life (QoL). Secondary endpoints were: i) development of a new or recurrent HIV disease progression event, including all-cause mortality; ii) switching from first- to second-line antiretroviral therapy (ART); and iii) occurrence of an adverse event. Intent-to-treat analysis, using linear regression mixed effects models were used to compare changes over time in the primary endpoints between the study arms. Kaplan-Meier time-toevent analysis and the log-rank test was used to compare HIV disease progression events and all-cause mortality. Results: Four hundred participants were randomized, 200 onto MV and 200 onto placebo. By month 18, the average change in CD4 cell count in the MV arm was 141 cells/uL compared to 147 cells/uL in the placebo arm, a mean difference of −6 · 17 [95 % CI −29 · 3, 16 · 9]. The average change in weight in the MV arm was 3 · 9 kg compared to 3 · 3 kg in the placebo arm, a mean difference of 0 · 54 [95 % CI −0 · 40, 1 · 48]; whereas average change in QoL scores in the MV arm was 6 · 8 compared to 8 · 8 in the placebo arm, a mean difference of −2.16 [95 % CI −4 · 59,0 · 27]. No significant differences were observed in these primary endpoints, or in occurrence of adverse events between the trial arms. Conclusions: One RDA of MV supplementation was safe but did not have an effect on indicators of disease progression among HIV infected adults initiating HAART.
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    Hematological Profiles of HIV-infected Adults Initiating Highly Active Antiretroviral Therapy (HAART) in Uganda
    (AIDS Research and Human Retroviruses, 2014) Kyeyune, Rachel; Saathoff, Elmar; Ezeamama, Amara; Fawzi, Wafaie; Loescher, Thomas; Guwatudde, David
    Cytopenias are the most common HIV-associated hematological abnormality. Cytopenias become more prevalent as HIV progresses and are often fatal. Sex, race, geographical location and comorbidities such as tuberculosis have been associated with cytopenias. Data from resource-limited settings about the prevalence, correlates and trends in cytopenia are limited. This analysis assessed the prevalence and correlates of cytopenia at initiation of HAART and the trend in cytopenias among HAART-treated AIDS patients in Uganda.
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    Multivitamin supplementation in HIV infected adults initiating antiretroviral therapy in Uganda: the protocol for a randomized double blinded placebo controlled efficacy trial
    (BMC Infectious Diseases, 2012) Guwatudde, David; Ezeamama, Amara E.; Bagenda, Danstan; Wabwire-Mangen, Fred; Wamani, Henry; Mugusi, Ferdinand; Spiegelman, Donna; Kyeyune, Rachel; Wang, Molin; Manabe, Yukari C.; Fawzi, Wafaie W.
    Use of multivitamin supplements during the pre-HAART era has been found to reduce viral load, enhance immune response, and generally improve clinical outcomes among HIV-infected adults. However, immune reconstitution is incomplete and significant mortality and opportunistic infections occur in spite of HAART. There is insufficient research information on whether multivitamin supplementation may be beneficial as adjunct therapy for HIV-infected individuals taking HAART. We propose to evaluate the efficacy of a single recommended daily allowance (RDA) of micronutrients (including vitamins B-complex, C, and E) in slowing disease progression among HIV-infected adults receiving HAART in Uganda. Methods/Design: We are using a randomized, double-blind, placebo-controlled trial study design. Eligible patients are HIV-positive adults aged at least 18 years, and are randomized to receive either a placebo; or multivitamins that include a single RDA of the following vitamins: 1.4 mg B1, 1.4 mg B2, 1.9 mg B6, 2.6 mcg B12, 18 mg niacin, 70 mg C, 10 mg E, and 0.4 mg folic acid. Participants are followed for up to 18 months with evaluations at baseline, 6, 12 and 18 months. The study is primarily powered to examine the effects on immune reconstitution, weight gain, and quality of life. In addition, we will examine the effects on other secondary outcomes including the risks of development of new or recurrent disease progression event, including all-cause mortality; ARV regimen change from first- to second-line therapy; and other adverse events as indicated by incident peripheral neuropathy, severe anemia, or diarrhea. Discussions: The conduct of this trial provides an opportunity to evaluate the potential benefits of this affordable adjunct therapy (multivitamin supplementation) among HIV-infected adults receiving HAART in a developing country setting.
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    The prevalence and clinical course of HIV-associated pulmonary cryptococcosis in Uganda
    (Journal of acquired immune deficiency syndromes, 2010) Yoo, Samuel D.; Worodria, William; Davis, J. L.; Cattamanchi, Adithya; Boon, Saskia den; Kyeyune, Rachel; Kisembo, Harriet; Huang, Laurence
    The prevalence and clinical course of pulmonary cryptococcosis in Sub-Saharan Africa are not well-described. Methods—Consecutive HIV-infected adults hospitalized at Mulago Hospital (Kampala, Uganda) between September 2007 and July 2008 with cough ≥ 2 weeks were enrolled. Patients with negative sputum smears for acid-fast bacilli were referred for bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid was examined for mycobacteria, Pneumocystis jirovecii, and fungi. Patients were followed two and six months after hospital discharge. Results—Of 407 patients enrolled, 132 (32%) underwent bronchoscopy. Of 132 BAL fungal cultures, 15 (11%) grew Cryptococcus neoformans. None of the patients were suspected to have pulmonary cryptococcosis on admission. The median CD4 count among those with pulmonary cryptococcosis was 23 cells/μL (IQR 7–51). Of 13 patients who completed six-month follow-up, four died and nine were improved, including five who had started antiretroviral therapy (ART) but had not received antifungal medication. Conclusions—Pulmonary cryptococcosis is common in HIV-infected TB suspects in Uganda. Early initiation of ART in those with isolated pulmonary infection may improve outcomes, even without anti-fungal therapy. This finding suggests that some HIV-infected patients with C. neoformans isolated from respiratory samples may have colonization or localized infection.
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    Prevalence and correlates of cytopenias in HIV-infected adults initiating highly active antiretroviral therapy in Uganda
    (BMC Infectious Diseases, 2014) Kyeyune, Rachel; Saathoff, Elmar; Ezeamama, Amara E.; Löscher, Thomas; Fawzi, Wafaie; Guwatudde, David
    Cytopenias are the most common HIV-associated hematological abnormality. Cytopenias have been associated with several factors including sex, race/ethnicity, geographical location and comorbidities such as tuberculosis, hepatitis B infection, fever and oral candidiasis. Cytopenias become more prevalent as HIV progresses and are often fatal. Data from resource-limited settings about the prevalence and correlates of cytopenia are limited. Therefore we conducted this cross-sectional study to assess the prevalence and correlates of cytopenia among adult AIDS patients at initiation of HAART in Uganda. Methods: 400 HIV-infected subjects who were HAART-naïve or on HAART for ≤ 6 months were enrolled into the Multivitamins, HAART and HIV/AIDS Trial. Anemia was defined according to WHO guidelines as any hemoglobin concentration < 12 g/dl for non-pregnant females and < 13 g/dl for males. Leucopenia and thrombocytopenia were defined using study site laboratory reference ranges for lack of generally accepted definitions for these 2 cell lines as leucopenia if white blood cell count < 2.75 × 109 cells/litre and thrombocytopenia if platelets < 125 × 109 cells/litre for females and < 156 × 109 cells/litre for males. Univariate and bivariate analyses were done to describe the patient population and log-binomial regression was used to quantify the correlates of cytopenia. Results: Sixty five percent of the 400 subjects had at least one form of cytopenia. Anemia occurred in 47.8%, leucopenia in 24.3%, thrombocytopenia in 8.3%, bicytopenia in 21.9% and only 2 had a pancytopenia. Cytopenia was more prevalent in females (prevalence ratio [PR]:1.33, 95% confidence interval [CI]:1.12-1.59); CD4 count category 50 to <200 (PR: 0.75, 95% CI: 0.64 -0.88) and CD4 count category 200 to <350 (PR: 0.74, 95% CI: 0.59 - 0.92) compared to CD4 count category <50; normal BMI (PR: 0.82, 95% CI:0.68-1.00) and overweight BMI (PR: 0.64, 95% CI:0.50- 0.82) compared to underweight BMI and those with a history or presence of oral candidiasis. Conclusions: Cytopenias are a frequent complication in HIV-infected adults at initiation of HAART in Uganda. The presence of any cytopenia was associated with female sex, decreasing CD4 count and decreasing body mass index. Prospective studies in resource-limited settings on the trend in HIV-related cytopenias are needed.