PROMISE Study Results

Updates from: 2020 2019 2018 2017 2016 2015 2014 2013

Updates in 2020

Kiweewa FM, Tierney C, Butler K, Peters MG, Vhembo T, Moodley D, Govender V, Mohtashemi N, Ship H, Musoke P, Dula D, George K, Chakhtoura N, Klingman KL, Fowler MG, Currier JS, Bhattacharya D. Infant Outcomes in HIV/Hepatitis B Co-Infected Women Initiating ART in the Promoting Maternal and Infant Survival Everywhere Study. Poster presentation at the American Association for the Study of Liver Diseases (AASLD), Virtual. November 2020.

Bhattacharya D, Tierney C, Butler K, Moodley D, Govender V, Vhembo T, Mohtashemi NZ, Ship H, Dula D, George K, Chakhtoura N, Klingman KL, Fowler MG, Peters MG, Currier JS. Safety And HBV Efficacy Of Antiretroviral Therapy In Women With HIV And HBV In The Promoting Maternal And Infant Survival Everywhere Study (PROMISE). Poster presentation at the American Association for the Study of Liver Diseases (AASLD), Virtual. November 2020.

Theron G, Brummel S, Fairlie L, Pinilla M, McCarthy K, Owor M, Chinula L, Makanani B, Violari A, Moodley D, Chakhtoura N, Browning R, Hoffman R, Fowler MG, PROMISE (Promoting Maternal and Infant Survival Everywhere) 1077BF and 1077FF Teams Pregnancy outcomes of women conceiving on antiretroviral therapy (ART) compared to those commenced on ART during pregnancy. Clin Infect Dis. 2020;ciaa805. doi:10.1093/cid/ciaa805

Angelidou K, Fowler MG, Flynn P, Coletti A, McCarthy K, Browning R, McIntyre J, Brummel SS, Shapiro DE, Tierney C; PROMISE study team. Enrollment and transition challenges in the International Maternal Pediatric and Adolescent AIDS Clinical Trials (IMPAACT) network's PROMISE trial for resource-limited regions. Clin Trials. 2020;17(4):437-447. doi:10.1177/1740774520912428

Bhattacharya D, Gupta A, Tierney C, Huang S, Peters MG, Chipato T, Martinson F, Mohtashemi N, Dula D, George K, Chakhtoura N, Klingman K, Gnanashanmugam D, Currier J, Fowler M. Hepatotoxicity and Liver-Related Mortality in Women of Child-Bearing Potential Living With HIV and High CD4 Counts Initiating Efavirenz-Containing Regimens. Clin Infect Dis. 2020;ciaa244. doi:10.1093/cid/ciaa244

Tobin NH, Murphy A, Li F, Brummel S, Fowler MG, McIntyre J, Currier JS, Chipato T, Flynn P, Koos B, Aldrovandi GM, and the PROMISE team. Metabolites, Preterm Labor and Antiretroviral Therapy. Poster presentation at the Conference for Retroviruses and Opportunistic Infections (CROI), Virtual; Boston, United States. March 2020.

Aizire J, Brooks K, Mirochnick M, Flynn P, Butler K, Kiser J, Siberry G, Fenton T, Cababasay M, Fowler MG for the PROMISE Study Team. Antenatal Intracellular Concentrations of Tenofovir Diphosphate and Emtricitabine Triphosphate and Associations Between Tenofovir Diphosphate and Severe Adverse Pregnancy Outcomes: IMPAACT-PROMISE (1077BF) Trial. J Acquir Immune Defic Syndr. 2020;83(2):173-180. doi:10.1097/QAI.0000000000002247

Aizire J, Sikorskii A, Ogwang LW, Kawalazira R, Mutebe A, Familiar-Lopez I, Mallewa M, Taha T, Boivin MG, Fowler MG, for the PROMISE-NEURODEV study team. Decreased growth among antiretroviral drug and HIV exposed uninfected versus unexposed children in Malawi and Uganda. AIDS. 2020;34(2):215-225. doi:10.1097/QAD.0000000000002405

Atuhaire P, S Brummel S, Mmbaga BT, Angelidou K, Fairlie L, Violari A, Theron G, Mukuzunga C, Mawlana S, Mubiana-Mbewe M, Naidoo M, Makanani B, Mandima P, Nematadzira T, Suryavanshi N, Mbengeranwa T, Loftis A, Basar M, McCarthy K, Currier JS, Fowler MG,1077BF/1077FF PROMISE Team. The impact of short term Antiretroviral Therapy (ART) interruptions on longer term maternal health outcomes-A randomized clinical trial. PLoS One. 2020;15(1):e0228003. Published 2020 Jan 30. doi:10.1371/journal.pone.0228003

Lesosky M, Raboud J, Glass T, Brummel SS, Ciarnello AL, Currier JS, Essajee S, Havlir DV, Koss CA, Ogwu A, Shapiro RL, Abrams EJ, Myer L. Comparison of guidelines for HIV viral load monitoring among pregnant and breastfeeding women in sub-Saharan Africa: a simulation study. AIDS. 2020;34(2):311-315. doi:10.1097/QAD.0000000000002400

Hoffman R, Warshaw M, Amico KR, Pilotto Jose, Masheto G, Achalapong J, Machado E, Chokephaibulkit K, Duarte G, João E, Graham KK, Knapp KM, Stek AM, Scott GB, Coletti A, Loftis AJ, Chakhtoura N, Currier JS, for the PROMISE 1077HS Team. Predictors of Viremia in Postpartum Women on Antiretroviral Therapy. J Acquir Immune Defic Syndr. 2020;83(1):72-80. doi:10.1097/QAI.0000000000002228

Updates in 2019

Hompe ED, Jacobson DL, Eudailey JA, Butler K, Edwards W, Pollara J, Brummel SS, Fouda GG, Chinula L, Kamanga M, Kinikar A, Moodley D, Owor M, Fowler MG, Permar SR. Maternal Humoral Immune Responses Do Not Predict Postnatal HIV-1 Transmission Risk in Antiretroviral-Treated Mothers from the IMPAACT PROMISE Study. mSphere. 2019; doi: 10.1128/mSphere.00716-19.

Venkatesh KK, Farhad M, Fenton T, Moodley D, Naik S, Nakabiito C, Fairlie L, Fowler MG, Stringer JSA, Chi BH. Association between HIV antiretroviral therapy and preterm birth based on antenatal ultrasound gestational age determination: a comparative analysis. AIDS. 2019;33(15):2403-2413. doi:10.1097/QAD.0000000000002367

Stranix-Chibanda L, Brummel S, Pilotto J, Mutambanengwe M, Chanaiwa V, Mhembere T, Kamateeka M, Aizire J, Masheto G, Chamanga R, Maluwa M, Hanley S, Joao E, Theron G, Nevrekar N, Nyati M, Santos B, Aurpibul L, Mubiana-Mbewe M, Oliveira R, Anekthananon T, Mlay P, Angelidou K, Tierney C, Ziemba L, Coletti A, McCarthy K, Basar M, Chakhtoura N, Browning R, Currier J, Fowler MG, Flynn P. Slow Acceptance of Universal Antiretroviral Therapy (ART) Among Mothers Enrolled in IMPAACT PROMISE Studies Across the Globe. AIDS Behav. 2019;23(9):2522-2531. doi:10.1007/s10461-019-02624-3

Sebikari D, Farhad M, Fenton T, Owor M, Stringer JSA, Qin M, Chakhtoura N, Chi BH, Saidi F, Nevrekar N, Violari A, Chipato T, McIntyre J, Moodley D, Taha TE, Thereon G, and Fowler MG. Risk Factors for Adverse Birth Outcomes in the PROMISE 1077BF/1077FF Trial. J Acquir Immune Defic Syndr. 2019;81(5):521-532. doi:10.1097/QAI.0000000000002072

Le CN, Britto P, Brummel SS, Hoffman RM, Li JZ, Flynn PM, Taha TE, Coletti A, Fowler MG, Bosch RJ, Gandhi RT, Klingman KL, McIntyre JA, Currier JS. Time to viral rebound and safety after antiretroviral treatment interruption in postpartum women compared to men. AIDS. 2019;33(14):2149-2156. doi:10.1097/QAD.0000000000002334

Murnane P, Bacchetti P, Currier JS, Brummel S, Okochi H, Phung N, Louie A, Kuncze K, Hoffman RM, Nematadzira T, Soko DK, Owor M, Saidi F, Flynn PM, Fowler MG, Gandhi M. Tenofovir concentrations in hair strongly predict virologic suppression in breastfeeding women. AIDS. 2019;33(10):1657-1662. doi:10.1097/QAD.0000000000002237

Boyce CL, Sils T, Ko D, Wong-on-Wing A, Styrchak S, Beck IA, DeMarrais P, Tierney C, Stranix-Chibanda L, Taha TE, Owor M, Fowler MG, Frenkel LM, for the PROMISE Study Team. HIV drug resistance at mother-to-child transmission and emergence during breastfeeding. Oral presentation at the International Workshop on HIV Pediatrics, Mexico City, Mexico. 2019 Jul 19-20.

Boivin M, Maliwichi-Senganimalunje L, Ogwang LW, Kawalazira R, Sikorskii A, Familiar-Lopez I, Kuteesa A, Nyakato M, Mutebe A, Namukooli JL, Mallewa M, Ruiseñor-Escudero H, Aizire J, Taha TE, Fowler MG. Neurodevelopmental effects of ante-partum and post-partum antiretroviral exposure in HIV-exposed and uninfected children versus HIV-unexposed and uninfected children in Uganda and Malawi: a prospective cohort study. Lancet HIV. 2019;6(8):e518-e530. doi:10.1016/S2352-3018(19)30083-9

Boyce CL, Beck IA, Sils T, Ko D, Wong-on-Wing A, Styrchak S, et al, for the PROMISE Study Team. HIV drug resistance at perinatal transmission and accumulation during breastfeeding. Poster presentation at the Conference for Retroviruses and Opportunistic Infections (CROI), Seattle, United States. March 2019.

Lesosky M, Raboud JM, Glass T, Brummel SS, Ciaranello AL, Currier JS, et al. Evaluation of guidelines for VL monitoring in pregnancy & breastfeeding: a simulation. Poster presentation at the Conference for Retroviruses and Opportunistic Infections (CROI), Seattle, United States. March 2019.

Murnane PM, Bacchetti P, Currier JS, Brummel S, Okochi H, Phung N, et al. Tenofovir hair levels rise over the postpartum period and highly predict viral loads. Poster presentation at the Conference for Retroviruses and Opportunistic Infections (CROI), Seattle, United States. March 2019.

Venkatesh K, Farhad M, Fenton T, Moodley D, Naik S, Nakabiito C, et al. Preterm birth among women with ultrasound-based gestational age dating in PROMISE 1077BF. Poster presentation at the Conference for Retroviruses and Opportunistic Infections (CROI), Seattle, United States. March 2019

Venkatesh K, Farhad M, Fenton T, Moodley D, Naik, S, Nakabiito C, et al. Diagnostic accuracy of clinical newborn assessment versus ultrasound to define preterm birth: the PROMISE trial. 39th Annual Pregnancy Meeting. Las Vegas, United States. February 2019.

Updates in 2018

Hoffman RM, Angelidou KN, Brummel SS, Saidi F, Violari A, Dula D, et al; IMPAACT PROMISE 1077BF/FF team. Maternal health outcomes among HIV-infected breastfeeding women with high CD4 counts: results of a treatment strategy trial. HIV Clin Trials. 2018 Dec;19(6):209-24. PMC6428202.

Boyce CL, Sils T, Milne R, Ko D, Wong-on-Wing A, Mackey M, et al. Association of HIV Drug Resistance Mutations with Virologic Failure in Women on Efavirenz-based Antiretroviral Therapy. 27th International Workshop on HIV Drug Resistance and Treatment Strategies. Johannesburg, South Africa. October 2018.

Aizire J, Brooks KM, Mirochnick M, Flynn P, Cababasay M, Kiser JJ, et al, and the PROMISE Study Team. Intracellular concentrations of tenofovir diphosphate (TFV-DP) during pregnancy in the PROMISE study: Description and relationship with adverse pregnancy outcomes. Poster presentation at the 10th International Workshop on HIV Pediatrics. Amsterdam, the Netherlands. July 2018.

Flynn P, Taha T, Cababasay M, Butler K, Fowler MG, Mofenson L, et al, and the PROMISE Study Team. Role of maternal viral load and CD4 count on perinatal HIV-1 transmission during breastfeeding in the PROMISE postpartum component. Oral presentation at the 10th International Workshop on HIV Pediatrics and poster presentation at the 23nd International AIDS Conference (IAS). Amsterdam, the Netherlands. July 2018.

Hoffman RM, Brummel SS, Britto P, Pilotto JH, Masheto G, Aurpibul L, et al; 1077HS PROMISE Team. Adverse Pregnancy Outcomes Among Women who Conceive on Antiretroviral Therapy. Clin Infect Dis. 1 Jun 2018. ePub ahead of print. Jan 2019;68(2):273-9. PMC6321847.

Flynn PM, Taha TE, Cababasay M, Fowler MG, Mofenson LM, Owor M, et al; PROMISE Study Team. Prevention of HIV-1 transmission through breastfeeding: efficacy and safety of maternal antiretroviral therapy versus infant nevirapine prophylaxis for duration of breastfeeding in HIV-1-infected women with high CD4 cell count (IMPAACT PROMISE): a randomized, open label, clinical trial. JAIDS. 11 Dec 2017. ePub ahead of print. 2018 Apr 1;77(4):383-392. PMC5825265.

Hoffman RM, Warshaw M, Amico KR, Pilotto JH, Masheto G, Achalapong J, et al, for the PROMISE 1077HS team. Predictors of virologic failure in postpartum women on ART in PROMISE 1077HS. Poster presentation at the Conference for Retroviruses and Opportunistic Infections (CROI), Boston, United States. March 2018.

Hoffman RM, Angelidou K, Brummel SS, Saidi F, Violari A, Dula D, et al, for the PROMISE 1077BF/FF team. Similar clinical outcomes between formula and breastfeeding women in PROMISE. Oral presentation at the Conference for Retroviruses and Opportunistic Infections (CROI), Boston, United States. March 2018.

Le CN, Britto P, Brummel S, Hoffman RM, Flynn PM, Taha TE, et al. HIV-1 viral rebound and safety outcomes of postpartum treatment interruption in women . Poster presentation at the Conference for Retroviruses and Opportunistic Infections (CROI), Boston, United States. March 2018.

Taha TE, Brummel S, Angelidou K, Fowler MG, Flynn PM, Mukuzunga C, et al, for the IMPAACT PROMISE Study Team. PROMISE trial: Results of continued vs discontinued ART after end of breastfeeding. Oral presentation at the Conference for Retroviruses and Opportunistic Infections (CROI), Boston, United States. March 2018.

Updates in 2017

Bhattacharya D, Gupta A, Tierney C, Huang S, Peters M, Chipato T, et al. Hepatotoxicity in HIV+ Postpartum Women Initiating Efavirenz-Containing Regimens. Oral presentation at the 9th International Workshop on HIV Pediatrics and poster presentation at the 22nd International AIDS Conference (IAS). Paris, France. July 2017.

Boivin M, Wambuzi Ogwang L, Kawalazira R, Maliwichi-Senganimalunje L, Sikorskii A, et al. Neurodevelopmental effects of type of antepartum and postpartum PMTCT ARV exposure on Ugandan and Malawian PROMISE HIV-exposed uninfected children at 12, 24, and 48 months of age. Poster presentation at the 9th International Workshop on HIV Pediatrics. Paris, France. July 2017.

Currier JS, Britto P, Hoffman RM, Brummel S, Masheto G, Joao E, et al, 1077HS PROMISE Team. Randomized trial of stopping or continuing ART among postpartum women with pre-ART CD4 ≥ 400 cells/mm3. PLoS One. 2017 May 10;12(5):e0176009. PMC5425014.

Kazemi L, Fan B, Sommer M, George K, Stranix-Chibanda L, Shepherd J. Tracking of spine BMD (Bone Mineral Density) in infants exposed to TDF (tenofovir disoproxil fumarate) medication in utero and/or breast feeding. Poster presentation at ISCD. Orlando, Florida, USA, April 2017.

Chi BH, Farhad M, Owor M, Chipato T, Qin M, Dadabhai S, et al. Antenatal antiretroviral therapy and adverse birth outcomes: the PROMISE trial. Poster presentation at the Conference for Retroviruses and Opportunistic Infections (CROI) Seattle, United States. February 2017.

Pilotto JH, Brummel S, Hoffman RM, Britto P, Masheto G, Aurpibul L, et al. Subsequent pregnancy outcomes in women during follow-up in PROMISE 1077HS. Poster presentation at the Conference for Retroviruses and Opportunistic Infections (CROI), Seattle, United States. February 2017.

Sebikari D, Qin M, Owor M, Stringer J, Farhad M, Chakhtoura N, et al. Risk factors for low birth weight and preterm delivery in the PROMISE trial. Poster presentation at the Conference for Retroviruses and Opportunistic Infections (CROI) Seattle, United States. February 2017.

Shepherd JA, Sommer MJ, Fan B, et al. Advanced Analysis Techniques Improve Infant Bone and Body Composition Measures by Dual-Energy X-Ray Absorptiometry. The Journal of Pediatrics. Feb 2017;181:248-253.e243. PMC5274603.

Updates in 2016

Publication of PROMISE Breastfeeding and Formula Feeding Versions Antepartum Results - November 7, 2016

Fowler MG, Qin M, Fiscus SA, Currier JS, Flynn PM, Chipato T, et al, for the IMPAACT 1077BF/1077FF PROMISE study team. Benefits and risks of Antiretroviral Therapy for Perinatal HIV Prevention. New England Journal of Medicine, 2016. 375(18): p. 1726-1737. PMC5214343.

PROMISE studies successfully closed to follow up - October 5, 2016

PROMISE at AIDS 2016 - July 2016

Taha T, Flynn P, Cababasay M, Fowler MG, Mofenson L, Owor M, et al, and the PROMISE Study Team. Comparing maternal triple antiretrovirals and infant nevirapine prophylaxis for the prevention of mother-to-child transmission of HIV during breastfeeding. Oral presentation at the 8th International Workshop on HIV Pediatrics and poster presentation at the 21st International AIDS Conference (AIDS 2016) Durban, South Africa. July 2016.

J Currier et al. Randomized trial of stopping or continuing ART among postpartum women with pre-ART CD4 ≥400 cells/mm^3 (PROMISE 1077HS). Oral presentation at the at the 21st International AIDS Conference (AIDS 2016) Durban, South Africa. July 2016.

L Stranix-Chibanda et al. Impact of maternal antiretroviral therapy (ART) versus infant nevirapine prophylaxis on somatic growth of breastfeeding infants in the PROMISE trial. Poster presentation at the 8th International Workshop on HIV Pediatrics. Durban, South Africa. July 2016.

L Stranix-Chibanda et al. Impact of tenofovir-containing triple antiretroviral therapy (ART) on bone mineral density in HIV-infected breastfeeding women in sub-Saharan Africa. Oral presentation at the 8th International Workshop on HIV Pediatrics. Durban, South Africa. July 2016.

L Stranix-Chibanda et al. Low acceptance of early antiretroviral therapy (ART) among postpartum women enrolled in IMPAACT PROMISE studies across the globe. Poster presentation at the 8th International Workshop on HIV Pediatrics and oral presentation at the 21st International AIDS Conference (AIDS 2016) Durban, South Africa. July 2016.

Siberry GK, Tierney C, Stranix-Chibanda L, Marr C, Shepherd JA, Browning R, et al. Impact of maternal tenofovir disoproxil fumarate on newborn bone mineral content. Oral presentation at the Conference for Retroviruses and Opportunistic Infections (CROI) Boston, United States. February 2016.

Updates in 2015

Fowler MG, Qin M, Fiscus S, Currier JS, Makanani B, Martinson FE, et al. Efficacy and Safety of 2 Strategies to Prevent Perinatal HIV Transmission. Poster presentation at the Conference for Retroviruses and Opportunistic Infections (CROI) Seattle, United States. February 2015.

Updates in 2014

PROMISE Breastfeeding and Formula Feeding Versions Report Antepartum Results and Promise HAART Standard Version to Complete Accrual - November 2014

PROMISE Study Now Closed to Accrual - October 2014

Shepherd JA, Fan B, Powers C, Stranix-Chibanda L, Fowler MG, DiMeglio LA, Mukwasi C, George K, Siberry G. Novel “3-6” infant DXA scanning and analysis protocols to isolate movement and other artifacts. FR0055, Poster presentation at the American Society of Bone and Mineral Research (ASBMR) Annual meeting. Houston, United States. September 2014. J Bone Miner Res 29 (Suppl 1). 2014.

Updates in 2013

Shepherd JA, Fan B, Powers CL, Stranix-Chibanda L, Fowler MG, DiMeglio LA, et al. Reflection analysis of infant scans results may improve infant DXA bone density and body composition result that contain motion. P156, Poster presentation at the International Conference on Children’s Bone Health, Rotterdam, NL, June 24, 2013.

Powers CL, Fan B, Shepherd JA, Stranix-Chibanda L, Fowler MG, DiMeglio LA, et al. Analyzing an infant whole body DXA scans – reflection or fusion? Poster presentation at the Annual Meeting of the International Society for Clinical Densitometry, Tampa, FL, March 21, 2013.