Browsing by Author "Pinilla M"

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    Effect on growth of exposure to maternal antiretroviral therapy in breastmilk versus extended infant nevirapine prophylaxis among HIV-exposed perinatally uninfected infants in the PROMISE randomized trial.
    (2021) Stranix-Chibanda L; Tierney C; Pinilla M; George K; Aizire J; Chipoka G; Mallewa M; Naidoo M; Nematadzira T; Kusakara B; Violari A; Mbengeranwa T; Njau B; Fairlie L; Theron G; Mubiana-Mbewe M; Khadse S; Browning R; Fowler MG; Siberry GK; University of Zimbabwe Faculty of Medicine and Health Sciences, Child and Adolescent Health Unit, Harare, Zimbabwe.; FHI 360, Durham, NC, United States of America.; Department of Obstetrics and Gynaecology, Stellenbosch University, Cape Town, South Africa.; Kilimanjaro Christian Medical Center, Moshi, United Republic of Tanzania.; Office of HIV/AIDS, United States Agency for International Development, Washington, DC, United States of America.; Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.; Department of Obstetrics and Gynaecology, BJ Government Medical College, Pune, India.; University of KwaZulu-Natal, Centre Aids Prevention Research South Africa (CAPRISA), Durban, South Africa.; Johns Hopkins University School of Medicine, Baltimore, MD, United States of America.; Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, MD, United States of America.; Makerere University-Johns Hopkins University Research Programme, Kampala, Uganda.; Perinatal HIV Research Unit, Johannesburg, South Africa.; College of Medicine-Johns Hopkins University Project, Blantyre, Malawi.; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States of America.; University of North Carolina Project, Lilongwe, Malawi.; University of Zimbabwe Clinical Trials Research Centre, Harare, Zimbabwe.; Harvard T.H. Chan School of Public Health, Center for Biostatistics in AIDS Research in the Department of Biostatistics, Boston, MA, United States of America.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    BACKGROUND: Malnutrition is highly prevalent in HIV-exposed perinatally uninfected infants (HEUs) increasing the risk of morbidity and mortality throughout the life course. We set out to compare the effect of postnatal exposure to maternal antiretroviral therapy (mART) in breastmilk versus infant Nevirapine prophylaxis (iNVP) on somatic growth of HEUs in the randomized PROMISE trial. METHODS AND FINDINGS: We randomized 2431 mothers with HIV and their 2444 HEUs from six African countries and India 6-14 days after delivery to mART or iNVP for prevention of breastmilk HIV transmission. The mART regimen contained tenofovir/emtricitabine (99%) plus lopinavir/ritonavir. Infant growth parameters were compared at postnatal week 10, 26, 74 and 104 using World Health Organization (WHO) z-scores for length-for-age (LAZ), weight-for-age (WAZ), and head circumference-for-age (HCAZ). Week 26 LAZ was the primary endpoint measure. Student T-tests compared mean LAZ, WAZ, and HCAZ; estimated mean and 95% confidence interval (CI) are presented. Maternal and infant baseline characteristics were comparable between study arms. The estimated median breastfeeding duration was 70 weeks. After a mean follow-up of 88 weeks, mean LAZ and WAZ were below the WHO reference population mean at all timepoints, whereas mean HCAZ was not. The mART and iNVP arms did not differ for the primary outcome measure of LAZ at week 26 (p-value = 0.39; estimated mean difference (95%CI) of -0.05 (-0.18, 0.07)) or any of the other secondary growth outcome measures or timepoints (all p-values≥0.16). Secondary analyses of the primary outcome measure adjusting for week 0 LAZ and other covariates did not change these results (all p-values≥0.09). However, infants assigned to mART were more likely to have stunting compared to iNVP infants at week 26 (odds ratio (95% CI): 1.28 (1.05, 1.57)). CONCLUSIONS: In HEUs, growth effects from postnatal exposure to mART compared to iNVP were comparable for measures on length, weight and head circumference with no clinically relevant differences between the groups. Despite breastfeeding into the second year of life, length and weight were below reference population means at all ages in both arms. Further investment is needed to optimize postnatal growth of infants born to women with HIV. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov number NCT01061151.
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    Effects of preterm birth, maternal ART and breastfeeding on 24-month infant HIV-free survival in a randomized trial.
    (2024-Jul-15) Dadabhai S; Chou VB; Pinilla M; Chinula L; Owor M; Violari A; Moodley D; Stranix-Chibanda L; Matubu TA; Chareka GT; Theron G; Kinikar AA; Mubiana-Mbewe M; Fairlie L; Bobat R; Mmbaga BT; Flynn PM; Taha TE; McCarthy KS; Browning R; Mofenson LM; Brummel SS; Fowler MG; FHI 360, Durham, NC.; St. Jude Children's Research Hospital, Memphis, TN.; Centre for Infectious Disease Research in Zambia, George CRS, Lusaka, Zambia.; National Institute of Allergy and Infectious Diseases/NIH, Rockville, MD.; B.J. Government Medical College, Department of Paediatrics, Pune, India.; Kamuzu University of Health Sciences-Johns Hopkins Research Project, Blantyre, Malawi.; Elizabeth Glaser Pediatric AIDS Foundation, Washington DC, USA.; University of North Carolina Project Malawi, Tidziwe Centre, Lilongwe, Malawi.; Kilimanjaro Christian Medical Centre, Kilimanjaro Clinical Research Institute and Kilimanjaro Christian Medical University College/Kilimanjaro CRS, Moshi, Tanzania.; Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD.; University of Zimbabwe Clinical Trials Research Centre, Belgravia, Harare, Zimbabwe.; Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.; Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Soweto.; Department of Paediatrics and Child Health, University of KwaZulu-Natal, Durban, South Africa.; MU-JHU Research Collaboration; Upper Mulago Hill Road, Kampala, Uganda.; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health.; Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg.; Child, Adolescent and Women's Health Department, Faculty of Medicine and Health Sciences, University of Zimbabwe, Avondale.; Department of Obstetrics and Gynaecology, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.; Centre for the AIDS Programme of Research in South Africa and School of Clinical Medicine, University of KwaZulu Natal, Congella, South Africa.; Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    BACKGROUND: IMPAACT 1077BF/FF (PROMISE) compared the safety/efficacy of two HIV antiretroviral therapy (ART) regimens to zidovudine (ZDV) alone during pregnancy for HIV prevention. PROMISE found an increased risk of preterm delivery (<37 weeks) with antepartum triple ART (TDF/FTC/LPV+r or ZDV/3TC/LPV+r) compared with ZDV alone. We assessed the impact of preterm birth, breastfeeding, and antepartum ART regimen on 24-month infant survival. METHODS: We compared HIV-free and overall survival at 24 months for liveborn infants by gestational age, time-varying breastfeeding status, and antepartum ART arm at 14 sites in Africa and India. Kaplan-Meier survival probabilities and Cox proportional hazards ratios were estimated. RESULTS: Three thousand four hundred and eighty-two live-born infants [568 (16.3%) preterm and 2914 (83.7%) term] were included. Preterm birth was significantly associated with lower HIV-free survival [0.85; 95% confidence interval (CI) 0.82-0.88] and lower overall survival (0.89; 95% CI 0.86-0.91) versus term birth (0.96; 95% CI 0.95-0.96). Very preterm birth (<34 weeks) was associated with low HIV-free survival (0.65; 95% CI 0.54-0.73) and low overall survival (0.66; 95% CI 0.56-0.74). Risk of HIV infection or death at 24 months was higher with TDF-ART than ZDV-ART (adjusted hazard ratio 2.37; 95% CI 1.21-4.64). Breastfeeding initiated near birth decreased risk of infection or death at 24 months (adjusted hazard ratio 0.05; 95% CI 0.03-0.08) compared with not breastfeeding. CONCLUSION: Preterm birth and antepartum TDF-ART were associated with lower 24-month HIV-free survival compared with term birth and ZDV-ART. Any breastfeeding strongly promoted HIV-free survival, especially if initiated close to birth. Reducing preterm birth and promoting infant feeding with breastmilk among HIV/antiretroviral drug-exposed infants remain global health priorities.