Incidence and Predictors of Pregnancy in Women Enrolled in Large Multi-National HIV Treatment Trials of the AIDS Clinical Trials Group

Omoz-Oarhe, Ayotunde E., Hughes, Michael D., Bao, Yajing, Short, William R., Mngqibisa, Rosie, Cohn, Susan E., Weinberg, Adriana, Rosa, Alberto LA, Collier, Ann, Samaneka, Wadzanai, Morroni, Chelsea ORCID: https://orcid.org/0000-0002-2026-6039 and Lockman, Shahin (2023) 'Incidence and Predictors of Pregnancy in Women Enrolled in Large Multi-National HIV Treatment Trials of the AIDS Clinical Trials Group'. JAIDS Journal of Acquired Immune Deficiency Syndromes, Vol 94, Issue 5, pp. 461-467.

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Abstract

Objectives:
Women are under-represented in clinical trials and must often commit to using contraception to enroll. We sought to determine the incidence and predictors of pregnancy in women participating in HIV treatment trials.

Design:
Individual participant data meta-analysis.

Methods:
We included data from multi-country HIV treatment trials conducted 2005-2019 by the AIDS Clinical Trials Group (ACTG) that included females with HIV who were of reproductive potential, did not intend to become pregnant, and agreed to use effective contraception during study treatment. We extracted data from all female participants of age 18-55 years, including occurrence and dates of pregnancy on-study however, only a few incident pregnancy predictor variables were available for analysis.

Results:
1,626 women from four trials were included. Over a median of 28 months (6,461 person-years) of follow-up, 143 (9%) women became pregnant, for an overall incidence of 2.2 pregnancies/100 person-years (range 0.5–3/100 person-years, by study). In multivariable analysis including baseline age, type of regimen and country as predictor variables, younger age remained the strongest predictor of incident pregnancy (p<0.0001 adjusted for country and ART regimen). CD4 and HIV-1 RNA were not associated with pregnancy incidence.

Conclusion:
Pregnancy incidence was 2.2/100 person-years in female participants of HIV treatment trials. Rather than leading to exclusion of young women from trials, this finding should prompt appropriate adaptations in study design and analysis for earlier generation of pregnancy safety information for drugs.

Item Type:	Article
Subjects:	WA Public Health > Health Problems of Special Population Groups > WA 309 Women's health WC Communicable Diseases > Virus Diseases > Acquired Immunodeficiency Syndrome. HIV Infections > WC 503 Acquired immunodeficiency syndrome. HIV infections WQ Obstetrics > Pregnancy > WQ 200 General works
Faculty: Department:	Clinical Sciences & International Health > Clinical Sciences Department Clinical Sciences & International Health > International Public Health Department
Digital Object Identifer (DOI):	https://doi.org/10.1097/qai.0000000000003299
SWORD Depositor:	JISC Pubrouter
Depositing User:	JISC Pubrouter
Date Deposited:	24 Oct 2023 15:10
Last Modified:	09 Oct 2024 03:14
URI:	https://archive.lstmed.ac.uk/id/eprint/23338

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