@article{fdi:010068708,
  title = {{G}etting pregnant in {HIV} clinical trials : women's choice and safety needs. {T}he experience from the {ANRS}12169-2{LADY} and {ANRS}12286-{MOBIDIP} trials},
  author = {{S}erris, {A}. and {Z}oungrana, {J}. and {D}iallo, {M}. and {T}oby, {R}. and {N}golle, {M}. {M}. and {L}e {G}ac, {S}. and {C}outherut, {J}. and {C}ournil, {A}mandine and {B}eaudrap, {P}ierre de and {K}oulla-{S}hiro, {S}. and {D}elaporte, {E}ric and {C}iaffi, {L}.},
  editor = {},
  language = {{ENG}},
  abstract = {{I}ntroduction: {P}regnancy is an exclusion criteria in most clinical trials involving antiretroviral therapy ({ART}) and modern contraception methods are systematically proposed to women of childbearing age. {N}evertheless pregnancies are often observed. {R}eproductive choices during clinical trials should be understood to adapt interventions to the level of risk for mother and baby safety. {O}ur goal was to describe the reproductive behavior and pregnancy outcomes among {HIV}-infected women on second-line antiretroviral treatment enrolled in two clinical trials and to compare them with those of {HIV}-positive women in non-research settings.{M}ethods: {T}he number and outcomes of pregnancies were recorded among 281 non menopausal women enrolled in the {ANRS} 12169-2{LADY} and {ANRS} 12286-{MOBIDIP} clinical trials in {C}ameroon, {S}enegal and {B}urkina {F}aso. {A}ll participants had agreed to use a least one contraceptive method (barrier or non-barrier) which was provided for free during the study. {D}ata were collected through revision of pregnancy notification forms and by data extraction from the study database, regularly updated and checked during the study.{R}esults: {S}ixty-six women had 84 pregnancies between {J}anuary 2010 and {J}uly 2015 resulting in a pregnancy rate of 8.0 per 100 women-years ({WY}) (95% {CI} 6.5-9.9) which is similar to the ones observed in cohort studies in {S}ub-{S}aharan {A}frica (varying from 2.5 to 9.4 pregnancies per 100 {WY}). {A}mong 60 live births, 10 (16.6%) were born prematurely and 9 (15%) had a low birth weight. {S}ixteen miscarriages/stillbirths occurred (19.5%). {T}his percentage is comparable to the one expected in the seronegative population which is reassuring for {HIV}-positive women considering pregnancy on {ART}. {O}nly one minor birth defect was diagnosed. {I}n univariate and multivariate analysis, miscarriages/stillbirths were not associated either with age, nadir of {CD}4 count, duration of {ART}, {CD}4 count, or viral load at the beginning of pregnancy.{C}onclusion: {HIV}-positive women participating in clinical trials conducted in {S}ub-{S}aharan {A}frica tend to get pregnant as often as seropositive women who received medical care in non-research settings. {I}t is therefore essential to adopt a pragmatic approach by re-evaluating the relevance of the criteria for exclusion of pregnant women according to the risk associated with exposure and to seek more effective and innovating contraceptive strategies when using potentially teratogenic molecules.},
  keywords = {{HIV} ; {C}linical trial ; {P}regnancy ; {P}regnancy outcomes ; {AFRIQUE} {SUBSAHARIENNE} ; {SENEGAL} ; {CAMEROUN} ; {BURKINA} {FASO}},
  booktitle = {},
  journal = {{HIV} {C}linical {T}rials},
  volume = {17},
  numero = {6},
  pages = {233--241},
  ISSN = {1528-4336},
  year = {2016},
  DOI = {10.1080/15284336.2016.1248624},
  URL = {https://www.documentation.ird.fr/hor/fdi:010068708},
}