Where are the pregnant and breastfeeding women in new pre-exposure prophylaxis trials? The imperative to overcome the evidence gap

Accelerating drug discovery for pregnant and lactating women living with HIV

(2021) Risa M Hoffman et al.   Journal of the International AIDS Society

Safety, adherence, and HIV-1 seroconversion among women using the dapivirine vaginal ring (DREAM): an open-label, extension study

(2021) Annalene Nel et al.   Lancet HIV

Safety, uptake, and use of a dapivirine vaginal ring for HIV-1 prevention in African women (HOPE): an open-label, extension study

(2021) Jared M Baeten et al.   Lancet HIV

Safety review of tenofovir disoproxil fumarate/emtricitabine pre-exposure prophylaxis for pregnant women at risk of HIV infection

(2021) Randy M. Stalter et al.   Expert Opinion On Drug Safety

Efficacy and safety of dolutegravir with emtricitabine and tenofovir alafenamide fumarate or tenofovir disoproxil fumarate, and efavirenz, emtricitabine, and tenofovir disoproxil fumarate HIV antiretroviral therapy regimens started in pregnancy (IMPAACT 2010/VESTED): a multicentre, open-label, randomised, controlled, phase 3 trial

(2021) Shahin Lockman et al.   LANCET

Ending the evidence gap for pregnancy, HIV and co‐infections: ethics guidance from the PHASES project

(2021) Anne Drapkin Lyerly et al.   Journal of the International AIDS Society

Incident HIV among pregnant and breastfeeding women in sub-Saharan Africa

(2020) Lauren A. Graybill et al.   AIDS

Tenofovir alafenamide use in pregnant and lactating women living with HIV

(2020) Ahizechukwu C. Eke et al.   Expert Opinion on Drug Metabolism & Toxicology

Emerging evidence from a systematic review of safety of pre‐exposure prophylaxis for pregnant and postpartum women: where are we now and where are we heading?

(2020) Dvora L Joseph Davey et al.   Journal of the International AIDS Society

Importance of inclusion of pregnant and breastfeeding women in COVID-19 therapeutic trials

(2020) Sylvia M LaCourse et al.   CLINICAL INFECTIOUS DISEASES

Defining gaps in pre-exposure prophylaxis delivery for pregnant and post-partum women in high-burden settings using an implementation science framework

(2020) Jillian Pintye et al.   Lancet HIV

Tenofovir diphosphate concentrations in dried blood spots from pregnant and postpartum adolescent and young women receiving daily observed pre-exposure prophylaxis in sub-Saharan Africa

(2020) Lynda Stranix-Chibanda et al.   CLINICAL INFECTIOUS DISEASES

Influences on early discontinuation and persistence of daily oral PrEP use among Kenyan adolescent girls and young women

(2020) Jillian Pintye et al.   JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES

Southern African guidelines on the safe, easy and effective use of pre-exposure prophylaxis: 2020

(2020) Linda-Gail Bekker et al.   SOUTHERN AFRICAN JOURNAL OF HIV MEDICINE

Pharmacokinetics of Dapivirine Transfer into Blood Plasma, Breast Milk, and Cervicovaginal Fluid of Lactating Women using the Dapivirine Vaginal Ring

(2019) Lisa M. Noguchi et al.   ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

Tenofovir Gel for Prevention of Herpes Simplex Virus Type 2 Acquisition: Findings From the VOICE Trial

(2019) Jeanne M Marrazzo et al.   JOURNAL OF INFECTIOUS DISEASES

Methodological considerations in evaluating pregnancy outcomes in women living with HIV

(2019) Amy L. Slogrove et al.   JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES

Pregnant women & vaccines against emerging epidemic threats: Ethics guidance for preparedness, research, and response

(2019) Carleigh B. Krubiner et al.   VACCINE

Neural-Tube Defects and Antiretroviral Treatment Regimens in Botswana

(2019) Rebecca Zash et al.   NEW ENGLAND JOURNAL OF MEDICINE

Women’s views about contraception requirements for biomedical research participation

(2019) Kristen A. Sullivan et al.   PLoS One

Prevalence and correlates of sexually transmitted infections in pregnancy in HIV-infected and- uninfected women in Cape Town, South Africa

(2019) Dvora L. Joseph Davey et al.   PLoS One

Topical Inserts: A Versatile Delivery Form for HIV Prevention

(2019) M. Melissa Peet et al.   Pharmaceutics

Tenofovir disoproxil fumarate intravaginal ring for HIV pre-exposure prophylaxis in sexually active women: a phase 1, single-blind, randomised, controlled trial

(2019) Marla J Keller et al.   Lancet HIV

Use of the dapivirine vaginal ring and effect on cervical cytology abnormalities

(2019) Krishnaveni Reddy et al.   AIDS

Dolutegravir: advancing ethical research in pregnancy

(2019) Anne Drapkin Lyerly   LANCET

Where Were the Women? Gender Parity in Clinical Trials

(2019) Robert H. Goldstein et al.   NEW ENGLAND JOURNAL OF MEDICINE

The landscape for HIV pre-exposure prophylaxis during pregnancy and breastfeeding in Malawi and Zambia: A qualitative study

(2019) Chifundo Zimba et al.   PLoS One

Pre-exposure prophylaxis uptake and early continuation among pregnant and post-partum women within maternal and child health clinics in Kenya: results from an implementation programme

(2019) John Kinuthia et al.   Lancet HIV

Evaluating outcomes of mother-infants pairs using dolutegravir for HIV treatment during pregnancy

(2018) Clara Grayhack et al.   AIDS

Pregnancy outcomes and infant growth among babies with in-utero exposure to tenofovir-based preexposure prophylaxis for HIV prevention

(2018) Renee Heffron et al.   AIDS

Increased Risk of HIV Acquisition Among Women Throughout Pregnancy and During the Postpartum Period: A Prospective Per-Coital-Act Analysis Among Women With HIV-Infected Partners

(2018) Kerry A Thomson et al.   JOURNAL OF INFECTIOUS DISEASES

Sexual risk during pregnancy and postpartum periods among HIV-infected and –uninfected South African women: Implications for primary and secondary HIV prevention interventions

(2018) Dvora Joseph Davey et al.   PLoS One

HIV treatment in pregnancy

(2018) Heather Bailey et al.   Lancet HIV

OUP accepted manuscript

(2018)   CLINICAL INFECTIOUS DISEASES

FAME-04: A Phase 1 trial to assess the safety, acceptability, pharmacokinetics and pharmacodynamics of film and gel formulations of tenofovir

(2018) Katherine E Bunge et al.   Journal of the International AIDS Society

How the CIOMS guidelines contribute to fair inclusion of pregnant women in research

(2018) Rieke van der Graaf et al.   BIOETHICS

Pregnancy and Infant Outcomes Among Women Using the Dapivirine Vaginal Ring in Early Pregnancy

(2018) Bonus Makanani et al.   JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES

Undue inducement, or unfair exclusion: considering a case study of pregnancy in an HIV prevention trial

(2017) Bridget G Haire et al.   JOURNAL OF MEDICAL ETHICS

Research with pregnant women: a call to action

(2017) Margaret Olivia Little et al.   Reproductive Health

Detectable Tenofovir Levels in Breast-Feeding Infants of Mothers Exposed to Topical Tenofovir

(2016) Lisa M. Noguchi et al.   ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

Long-term follow-up of HIV seroconverters in microbicide trials – rationale, study design, and challenges in MTN-015

(2016) Sharon A. Riddler et al.   HIV CLINICAL TRIALS

Safety and Efficacy of a Dapivirine Vaginal Ring for HIV Prevention in Women

(2016) Annalene Nel et al.   NEW ENGLAND JOURNAL OF MEDICINE

Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women

(2016) Jared M. Baeten et al.   NEW ENGLAND JOURNAL OF MEDICINE

Benefits and Risks of Antiretroviral Therapy for Perinatal HIV Prevention

(2016) Mary G. Fowler et al.   NEW ENGLAND JOURNAL OF MEDICINE

A randomized safety and pharmacokinetic trial of daily tenofovir 1% gel in term and near-term pregnancy

(2016) Richard H Beigi et al.   Journal of the International AIDS Society

Successful discontinuation of the placebo arm and provision of an effective HIV prevention product after a positive interim efficacy result

(2014) Patrick Ndase et al.   JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES

FEM-PrEP

(2014) Amy L. Corneli et al.   JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES

4′-Ethynyl-2-fluoro-2′-deoxyadenosine (EFdA) Inhibits HIV-1 Reverse Transcriptase with Multiple Mechanisms

(2014) Eleftherios Michailidis et al.   JOURNAL OF BIOLOGICAL CHEMISTRY

Incident HIV during Pregnancy and Postpartum and Risk of Mother-to-Child HIV Transmission: A Systematic Review and Meta-Analysis

(2014) Alison L. Drake et al.   PLOS MEDICINE

Pharmacokinetics and Safety of Tenofovir in HIV-Infected Women During Labor and Their Infants During the First Week of Life

(2013) Mark Mirochnick et al.   JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES

Antiretroviral Prophylaxis for HIV Prevention in Heterosexual Men and Women

(2012) Jared M. Baeten et al.   NEW ENGLAND JOURNAL OF MEDICINE

Preexposure Prophylaxis for HIV Infection among African Women

(2012) Lut Van Damme et al.   NEW ENGLAND JOURNAL OF MEDICINE

Pharmacokinetics and Safety of Single-Dose Tenofovir Disoproxil Fumarate and Emtricitabine in HIV-1-Infected Pregnant Women and Their Infants

(2011) Patricia M. Flynn et al.   ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

Incident HIV Infection in Pregnant and Lactating Women and Its Effect on Mother-to-Child Transmission in South Africa

(2011) Dhayendre Moodley et al.   JOURNAL OF INFECTIOUS DISEASES

Pharmacokinetics and Placental Transfer of Single-Dose Tenofovir 1% Vaginal Gel in Term Pregnancy

(2011) Richard Beigi et al.   JOURNAL OF INFECTIOUS DISEASES