Trial reportPloS one2017
Randomized trial of stopping or continuing ART among postpartum women with pre-ART CD4 ≥ 400 cells/mm3.
Trial report in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00955968 (IMPAACT 1077HS), which is not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
IMPAACT 1077HS: HAART Standard Version of the Promoting Maternal and Infant Survival Everywhere (PROMISE) Study
Who cites it
19 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.
- Vulnerability and non-adherence to treatment in cisgender women living with HIV/AIDS: a scoping review (2000-2024).Archives of public health = Archives belges de sante publique · 2026Pooled it
- A pilot pragmatic trial of a "what matters most"-based intervention targeting intersectional stigma related to being pregnant and living with HIV in Botswana.AIDS research and therapy · 2022Trial
- Pregnancy Outcomes of Women Conceiving on Antiretroviral Therapy (ART) Compared to Those Commenced on ART During Pregnancy.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021Trial
- Hepatotoxicity and Liver-Related Mortality in Women of Childbearing Potential Living With Human Immunodeficiency Virus and High CD4 Cell Counts Initiating Efavirenz-Containing Regimens.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021Trial
- Trial
- Trial
- Predictors of Viremia in Postpartum Women on Antiretroviral Therapy.Journal of acquired immune deficiency syndromes (1999) · 2020Trial
- Association between HIV antiretroviral therapy and preterm birth based on antenatal ultrasound gestational age determination: a comparative analysis.AIDS (London, England) · 2019Trial
- Time to viral rebound and safety after antiretroviral treatment interruption in postpartum women compared with men.AIDS (London, England) · 2019Trial
- Slow Acceptance of Universal Antiretroviral Therapy (ART) Among Mothers Enrolled in IMPAACT PROMISE Studies Across the Globe.AIDS and behavior · 2019Trial
- Adverse Pregnancy Outcomes Among Women Who Conceive on Antiretroviral Therapy.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019Trial
- Maternal health outcomes among HIV-infected breastfeeding women with high CD4 counts: results of a treatment strategy trial.HIV clinical trials · 2018Trial
- Maternal-Child Human Immunodeficiency Virus Clinical Trials Networks across the Ages.Clinics in perinatology · 2024Review
- Assessment of the effect of pre-conception care on preventing mother-to-child transmission of HIV in Nyeri County.The Pan African medical journal · 2024Article
- Ethically designing research to inform multidimensional, rapidly evolving policy decisions: Lessons learned from the PROMISE HIV Perinatal Prevention Trial.Clinical trials (London, England) · 2021Review
- Stigma, Structural Vulnerability, and "What Matters Most" Among Women Living With HIV in Botswana, 2017.American journal of public health · 2021Article
- Article
- Tenofovir concentrations in hair strongly predict virologic suppression in breastfeeding women.AIDS (London, England) · 2019Article
- What is new in perinatal HIV prevention?Current opinion in pediatrics · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors at 13 institutions in 6 countries.
Funding
Abstract
backgroundHealth benefits of postpartum antiretroviral therapy (ART) for human immunodeficiency virus (HIV) positive women with high CD4+ T-counts have not been assessed in randomized trials.
methodsAsymptomatic, HIV-positive, non-breastfeeding women with pre-ART CD4+ T-cell counts ≥ 400 cells/mm3 started on ART during pregnancy were randomized up to 42 days after delivery to continue or discontinue ART. Lopinavir/ritonavir plus tenofovir/emtricitabine was the preferred ART regimen. The sample size was selected to provide 88% power to detect a 50% reduction from an annualized primary event rate of 2.07%. A post-hoc analysis evaluated HIV/AIDS-related and World Health Organization (WHO) Stage 2 and 3 events. All analyses were intent to treat.
results1652 women from 52 sites in Argentina, Botswana, Brazil, China, Haiti, Peru, Thailand and the US were enrolled (1/2010-11/2014). Median age was 28 years and major racial categories were Black African (28%), Asian (25%) White (15%). Median entry CD4 count was 696 cells/mm3 (IQR 575-869), median ART exposure prior to delivery was 19 weeks (IQR 13-24) and 94% had entry HIV-1 RNA < 1000 copies/ml. After a median follow-up of 2.3 years, the primary composite endpoint rate was significantly lower than expected, and not significantly different between arms (continue arm 0.21 /100 person years(py); discontinue 0.31/100 py, Hazard ratio (HR) 0.68, 95% CI: 0.19, 2.40). WHO Stage 2 and 3 events were significantly reduced with continued ART (2.08/100 py vs. 4.36/100 py in the discontinue arm; HR 0.48, 95%CI: 0.33, 0.70). Toxicity rates did not differ significantly between arms. Among women randomized to continue ART, 189/827 (23%) had virologic failure; of the 155 with resistance testing, 103 (66%) failed without resistance to their current regimen, suggesting non-adherence.
conclusionsOverall, serious clinical events were rare among young HIV-positive post-partum women with high CD4 cell counts. Continued ART was safe and was associated with a halving of the rate of WHO 2/3 conditions. Virologic failure rates were high, underscoring the urgent need to improve adherence in this population.
trial registrationClinicalTrials.gov NCT00955968.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.