ING200336, Pharmacokinetic and Safety Study in Pregnant Women With Human Immuno Virus Infection

Inclusion Criteria:

• HIV infected females participating in ING117172 on the DTG/ABC/3TC treatment arm whobecame pregnant with a singleton and have not met any safety or confirmed virologicwithdrawal criteria.
• Signed and dated written informed consent is obtained from the subject or thesubject's legal representative prior to screening.
• Willingness and intent to continue pregnancy
• Willingness to continue to receive DTG/ABC/3TC FDC.
• Willingness to enter the Antiretroviral Pregnancy Registry.
• Willingness to share medical information about herself and her infant for collectionof delivery and infant outcomes as it relates to this study.
• Subjects enrolled in France: a subject will be eligible for inclusion in this studyonly if either affiliated to or a beneficiary of a social security category.

Exclusion Criteria:

• History of allergy/sensitivity to DTG, ABC and/or 3TC.
• History of severe pre-clampsia, eclampsia, or hemolysis, elevated liver enzymes andlow platelet count (HELLP)
• Any evidence of an active Center for Disease Control and Prevention (CDC) Category Cdisease, except cutaneous Kaposi's sarcoma not requiring systemic therapy or historicor current CD4+ cell levels <200 cells/millimeter^3.
• Subjects with any degree of hepatic impairment.
• Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, orresected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelialneoplasia; other localized malignancies require agreement between the investigator andthe Study medical monitor for inclusion of the subject.
• Subjects who in the investigator's judgment, poses a significant suicidality risk.Recent history of suicidal behavior and/or suicidal ideation may be considered asevidence of serious suicide risk.
• Subjects with evidence of ongoing hepatitis B infection at screening, or anticipatedneed for Hepatitis C Virus therapy during the study.
• Treatment with any of the following agents within 28 days of Baseline: radiationtherapy; cytotoxic chemotherapeutic agents; any immunomodulators that alter immuneresponses.
• Subjects enrolled in France: the subject has participated in any study using aninvestigational drug during the previous 60 days or 5 half-lives, or twice theduration of the biological effect of the experimental drug or vaccine, whichever islonger, prior to screening for the study or the subject will participatesimultaneously in another clinical study.
• Any verified Grade 4 laboratory abnormality with the exception of Grade 4 lipidabnormalities (total cholesterol, triglycerides, high density lipoprotein [HDL]cholesterol, low density lipoprotein [LDL] cholesterol). A single repeat test isallowed during the Screening period to verify a result.
• Any acute laboratory abnormality observed in ING117172 or in any Screening laboratoryassessments for ING200336, which, in the opinion of the Investigator, would precludethe subject's participation in the study.
• Hyperbilirubinemia of unknown etiology.
• Confirmed (with no more than 1 repeat evaluation) Grade >= 2 urine protein (dipstick),serum creatinine, total bilirubin, alanine aminotransferase or aspartateaminotransferase at the time of the screening lab.
• Subject has Creatinine Clearance of <50 mL/minute via Cockroft-Gault method at thetime of the screening visit