NCT02249962: S4

Option B+: ART Safety and Durability During First and Subsequent Pregnancies

Completed Last updated 10 March 2021

What this trial tests

trial in HIV in 12,011 participants. Completed in 1 September 2020.

Timeline

1 May 2015

Primary endpoint
1 September 2020

1 September 2020

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Status	Completed
Study type	OBSERVATIONAL
Enrollment	12,011
Start date	1 May 2015
Primary completion	1 September 2020
Estimated completion	1 September 2020
Sites	1 location across Malawi

Conditions studied

• HIV — all drugs for HIV →
• Infant Exposure to Efavirenz — all drugs for Infant Exposure to Efavirenz →

Sponsor

University of North Carolina, Chapel Hill

Who can join

Adults 16 to 50, female only, with HIV or Infant Exposure to Efavirenz. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Proportion of participants with failure on Option B+ first-line treatment
  Time frame: Up to 36 months
  Proportion of women who fail first-line treatment as indicated by one or more of the following criteria: WHO Stage 3 or 4 events (as defined by Appendix 60 of the Adult AIDS Clinical Trials Group (AACTG)), or DAIDS grade 3 or 4 toxicity (lab serum markers), or proportion with treatment discontinuation (or death), or proportion with virologic failure (as measured by HIV RNA levels)

Sponsor's own description

To characterize safety, durability, antiretroviral treatment (ART) resistance, and clinical outcomes for mothers and infants exposed to the efavirenz-based Option B+ regimen for Prevention of Mother to Child Transmission (PMTCT) and HIV treatment in Malawi.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Accuracy of measures for antiretroviral adherence in people living with HIV.
   Smith R, Villanueva G, Probyn K, Sguassero Y, et al · · 2022 · cited 34× · PMID 35871531 · DOI 10.1002/14651858.cd013080.pub2
2. Prevalence and incidence of probable perinatal depression among women enrolled in Option B+ antenatal HIV care in Malawi.
   Harrington BJ, Hosseinipour MC, Maliwichi M, Phulusa J, et al · · 2018 · cited 17× · PMID 29990658 · DOI 10.1016/j.jad.2018.06.001
3. Prevalence and factors associated with antenatal depressive symptoms among women enrolled in Option B+ antenatal HIV care in Malawi: a cross-sectional analysis.
   Harrington BJ, Pence BW, John M, Melhado CG, et al · · 2019 · cited 13× · PMID 30270683 · DOI 10.1080/09638237.2018.1487542
4. Locally contextualizing understandings of depression, the EPDS, and PHQ-9 among a sample of postpartum women living with HIV in Malawi.
   Harrington BJ, Klyn LL, Ruegsegger LM, Thom A, et al · · 2021 · cited 11× · PMID 33272687 · DOI 10.1016/j.jad.2020.10.063
5. Factors associated with a history of treatment interruption among pregnant women living with HIV in Malawi: A cross-sectional study.
   Sasse SA, Harrington BJ, DiPrete BL, Chagomerana MB, et al · · 2022 · cited 6× · PMID 35439264 · DOI 10.1371/journal.pone.0267085
6. Probable perinatal depression and social support among women enrolled in Malawi's Option B+ Program: A longitudinal analysis.
   Bhushan NL, Stockton MA, Harrington BJ, DiPrete BL, et al · · 2022 · cited 6× · PMID 35314248 · DOI 10.1016/j.jad.2022.03.017
7. Probable antenatal depression at antiretroviral initiation and postpartum viral suppression and engagement in care.
   Harrington BJ, Pence BW, Maliwichi M, Jumbe AN, et al · · 2018 · cited 5× · PMID 30234603 · DOI 10.1097/qad.0000000000002025
8. Three-year outcomes for women newly initiated on lifelong antiretroviral therapy during pregnancy - Malawi option B.
   Chagomerana MB, Harrington BJ, DiPrete BL, Wallie S, et al · · 2023 · cited 4× · PMID 37308909 · DOI 10.1186/s12981-023-00523-1