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The purpose of this study is to assess the safety and effectiveness of DTG use in HIV positive pregnant women. This is a 3-year multi-site prospective observational study. Approximately, 250 HIV positive pregnant women from potential European AIDS Treatment Network (NEAT ID) sites across Europe will be enrolled. The enrollment period will be over 2 years with a follow-up period of 1 year for outcomes. The data collected will be that obtained during routine standard of care assessments; and the subjects will not undergo any interventional study procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV positive pregnant women | Data from approximately 250 HIV positive pregnant women with exposure to DTG from potential investigational sites across Europe will be included. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTG | Drug | Subjects with DTG exposure during any trimester will be included |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of female subjects with spontaneous abortion | Spontaneous abortion is defined as death of a fetus or expulsion of the products of conception before 22 weeks gestation. | Up to 1 year |
| Number of female subjects with induced abortion | Induced abortion is defined as voluntary termination of pregnancy before 22 weeks gestation. | Up to 1 year |
| Number of female subjects giving still births | Still birth is defined as the death of a fetus occurring at 22 weeks of gestation or more, or for situations in which the gestational age is unavailable, a fetus weighing at least 500 grams. | Up to 1 year |
| Number of female subjects with multiple births | Number of female subjects giving multiple births will be reported. | Up to 1 year |
| Number of female subjects with type of deliveries | The different type of deliveries will be summarized. | Up to 1 year |
| Maternal viral load (VL) at delivery | The maternal viral load at the time of delivery will be summarized. | Up to 1 year |
| Number of infants with birth defects | Birth defects will be classified according to World Health Organization's International Classification of Diseases, Tenth Revision. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of female subjects with drug related Adverse Events and Serious Adverse Events | Number of females with all drug related Adverse Events and Serious Adverse Events will be reported. These will be categorized by trimester of initiation. | Up to 1 year |
| Rate of DTG discontinuation in pregnant women |
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Inclusion Criteria:
Exclusion Criteria:
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HIV positive pregnant women
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Approximately, 250 HIV positive pregnant women having exposure to DTG from potential NEAT ID investigational sites across Europe will be enrolled.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US GSK Clinical Trials Call Center | Contact | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
| EU GSK Clinical Trials Call Center | Contact | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | ViiV Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Recruiting | Barcelona | 08041 | Spain |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| Gestational age | Number of females with birth collected data for gestational age as a measure of birth defects will be reported. | Up to 1 year |
| Birth weight | Number of females with birth collected data for birth weight as a measure of birth defects will be reported. | Up to 1 year |
| Number of female subjects giving premature births | Premature birth is defined as birth of live infant at <32 weeks gestation | Up to 1 year |
| Number of female subjects giving live births | Number of female subjects giving live births will be reported. | Up to 1 year |
| Infants with low birth weight | Low birth weight is defined as birth weight of <2500 grams. | Up to 1 year |
| Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score in infants | APGAR score in infants as a measure of birth defects will be calculated. | Up to 1 year |
| HIV status of Infants | Infant's HIV status as a measure of birth defects will be reported. | Up to 1 year |
Number of pregnant females with discontinuation of DTG will be reported. |
| Up to 1 year |
| Number of participants who discontinued DTG | Reasons for DTG discontinuation will be summarized. Number of participants who discontinued DTG will be reported. | Up to 1 year |
| Number of participants with VL at discontinuation | VL at discontinuation will be summarized to assess suppression. Number of participants with VL at discontinuation will be reported. | Up to 1 year |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |