evidence-based blog of Filippo Dibari

Posts Tagged ‘antiretroviral drugs’

Development of a crossover-randomized trial method to determine the acceptability and safety of novel ready-to-use therapeutic foods (ahead of print)

In Under-nutrition on September 19, 2012 at 5:07 pm

by Dibari F, Bahwere P, Huerga H, Irena AH, Owino V, Collins S, Seal A.

Nutrition (article in press).


Objective: To develop a method for determining the acceptability and safety of ready-to-use therapeutic foods (RUTF) before clinical trialing. Acceptability was defined using a combination of three consumption, nine safety, and six preference criteria. These were used to compare a soy/maize/sorghum RUTF (SMS-RUTFh), designed for the rehabilitation of human immunodeficiency virus/tuberculosis (HIV/TB) wasted adults, with a peanut-butter/milk-powder paste (P-RUTF; brand: Plumpy’nut) designed for pediatric treatment.

Methods: A cross-over, randomized, controlled trial was conducted in Kenya. Ten days of repeated measures of product intake by 41 HIV/TB patients, >18 y old, body mass index (BMI) 18-24 kg/m^2, 250 g were offered daily under direct observation as a replacement lunch meal. Consumption, comorbidity, and preferences were recorded.

Results: The study arms had similar age, sex, marital status, initial BMI, and middle upper-arm circumference. No carryover effect or serious adverse events were found. SMS-RUTFh energy intake was not statistically different from the control, when adjusted for BMI on day 1, and the presence of throat sores. General preference, taste, and sweetness scores were higher for SMS-RUTFh compared to the control (P < 0.05). Most consumption, safety, and preference criteria for SMS-RUTFh were satisfied except for the average number of days of nausea (0.16 versus 0.09 d) and vomiting (0.04 versus 0.02 d), which occurred with a higher frequency (P < 0.05).

Conclusion: SMS-RUTFh appears to be acceptable and can be safely clinically trialed, if close monitoring of vomiting and nausea is included. The method reported here is a useful and feasible approach for testing the acceptability of ready-to-use foods in low income countries.

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Use of Lipid-Based Nutrient Supplements by HIV-Infected Malawian Women during Lactation Has No Effect on Infant Growth from 0 to 24 Weeks

In Under-nutrition on May 31, 2012 at 6:23 am

by Valerie L. Flax5, Margaret E. Bentley, Charles S. Chasela, Dumbani Kayira, Michael G. Hudgens, Rodney J. Knight, Alice Soko, Denise J. Jamieson, Charles M. van der Horst, and Linda S. Adair

J. Nutr. July 1, 2012


The Breastfeeding, Antiretrovirals, and Nutrition study evaluated the effect of daily consumption of lipid-based nutrient supplements (LNS) by 2121 lactating, HIV-infected mothers on the growth of their exclusively breast-fed, HIV-uninfected infants from 0 to 24 wk. The study had a 2 × 3 factorial design. Malawian mothers with CD4+ ≥250 cells/mm3, hemoglobin ≥70 g/L, and BMI ≥17 kg/m2 were randomized within 36 h of delivery to receive either no LNS or 140 g/d of LNS to meet lactation energy and protein needs, and mother-infant pairs were assigned to maternal antiretroviral drugs (ARV), infant ARV, or no ARV. Sex-stratified, longitudinal, random effects models were used to estimate the effect of the 6 study arms on infant weight, length, and BMI. Logistic regression models were used to calculate the odds of growth faltering [decline in weight-for-age Z-score (WAZ) or length-for-age Z-score (LAZ) >0.67] using the control arm as the reference. Although some differences between study arms emerged with increasing infant age in boys, there were no consistent effects of the maternal supplement across the 3 growth outcomes in longitudinal models. At the ages where differences were observed, the effects on weight and BMI were quite small (≤200 g and ≤0.4 kg/m2) and unlikely to be of clinical importance. Overall, 21 and 34% of infants faltered in WAZ and LAZ, respectively. Maternal supplementation did not reduce the odds of infant weight or length faltering from 0 to 24 wk in any arm. These results indicate that blanket supplementation of HIV-infected lactating women may have little impact on infant growth.


For more information on LNS products you can browse in this blog. 

HIV and Nutrition: ProNUT HIV Stakeholder Consultation Report 2011

In Under-nutrition on May 25, 2012 at 9:23 am

“In October 2011, FANTA-2 assumed responsibility for moderating the ProNUT HIV e-forum, part of ProNUTRITION, a United States Agency for International Development (USAID)-funded interactive, online information resource that supports health care providers, community health workers, policy makers, and program managers with current, relevant, and practical knowledge and tools for decision making in the context of nutrition and HIV and related areas. To ensure that ProNUT was meeting its goals, FANTA‑2 consulted with ProNUT stakeholders by conducting a user survey to gather data on defining the direction of the e-forum and on improving ownership and participation. This report discusses findings from the survey and makes some recommendations on how to make ProNUT more accessible and more useful”.

Download the report. 

Association of BMI Category Change with TB Treatment Mortality in HIV-Positive Smear-Negative and Extrapulmonary TB Patients in Myanmar and Zimbabwe

In Under-nutrition on May 8, 2012 at 11:18 am

Benova L, Fielding K, Greig J, Nyang’wa BT, Casas EC, da Fonseca MS, du Cros P.

PLoS One. 2012;7(4):e35948. Epub 2012 Apr 2

“OBJECTIVE: The HIV epidemic has increased the proportion of patients with smear-negative and extrapulmonary tuberculosis (TB) diagnoses, with related higher rates of poor TB treatment outcomes. Unlike in smear-positive pulmonary TB, no interim markers of TB treatment progress are systematically used to identify individuals most at risk of mortality. The objective of this study was to assess the association of body mass index (BMI) change at 1 month (±15 days) from TB treatment start with mortality among HIV-positive individuals with smear-negative and extrapulmonary TB.

“METHODS AND FINDINGS: A retrospective cohort study of adult HIV-positive new TB patients in Médecins Sans Frontières (MSF) treatment programmes in Myanmar and Zimbabwe was conducted using Cox proportional hazards regression to estimate the association between BMI category change and mortality. A cohort of 1090 TB patients (605 smear-negative and 485 extrapulmonary) was followed during TB treatment with mortality rate of 28.9 per 100 person-years. In multivariable analyses, remaining severely underweight or moving to a lower BMI category increased mortality (adjusted hazard ratio 4.05, 95% confidence interval 2.77-5.91, p<0.001) compared with remaining in the same or moving to a higher BMI category.

“CONCLUSIONS: We found a strong association between BMI category change during the first month of TB treatment and mortality. BMI category change could be used to identify individuals most at risk of mortality during TB treatment among smear-negative and extrapulmonary patients.”

Nutritional support for African adults starting antiretroviral therapy (NUSTART) – a clinical trial

In Under-nutrition on May 5, 2012 at 2:37 pm

Background of the Trial. Micronutrient deficiencies and altered mineral metabolism associated with wasting malnutrition are potential risk factors for death among African patients referred for anti‐retroviral therapy (ART). We will conduct a randomized controlled phase III trial of a lipid‐based nutrient supplement (LNS)* without or with vitamins and bulk minerals during the first weeks after referral for ART.

* Also known as lipid-based, ready-to-use food for nutrition rehabilitation.

“A number of important universities is conducting an interesting randomized controlled clinical trial to test a lipid-base, ready-to-use food in adults, ART naive, with BMI < 18.5 kg/m2, requiring ART as determined by CD4 count < 350/l. The primary outcome consists of survival from the time of referral for ART to 12 weeks after starting ART, whereas the secondary outcomes are hospitalization from referral for ART to 12 weeks after starting ART, gain in lean body mass, and change in serum phosphate.

“All participants will receive a stepped regimen of LNS: this comprises a small daily dose of LNS (SDLNS) containing limited calories, from time of referral for ART through the pre‐ART preparation phase and until 2 weeks after start of ART, and then a larger daily dose of LNS containing a greater calorie provision (LD‐LNS) for four weeks, i.e., from 2 to 6 weeks after start of ART.

“The investigators are: Professor Suzanne Filteau (principal investigator), London School of Hygiene & Tropical Medicine; Professor Henrik Friis, University of Copenhagen; Dr Paul Kelly, Barts & The London School of Medicine and University Teaching Hospital, Lusaka; Dr Lackson Kasonka, University Teaching Hospital, Lusaka; Mr John Changalucha, Mwanza Medical Research Centre, Tanzania; Dr. Tsinuel Girma. Jimma University Specialised Hospital, Ethiopia; Dr. Douglas Heimburger, Vanderbilt University, USA; Dr. Aase Bengaard Andersen, University of Odense, Denmark; Dr. John Koethe, Vanderbilt University, USA.”

More informations are available on this document.

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