Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed
Brief Summary: The primary objective of this study is to evaluate the efficacy of switching from a regimen of dolutegravir (DTG) and abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing DTG and ABC/3TC as the FDC ABC/DTG/3TC in virologically suppressed Human Immunodeficiency Virus- 1 (HIV-1) infected adults.


Options:
A: Inclusion Criteria:

* Pregnant or breastfeeding women receiving care in one of the participating maternal and child health clinics
* HIV-exposed infants born from participating mothers

Exclusion Criteria:

* refuse to participate
B: Inclusion Criteria:

* documented CHB infection with HBsAg positive \> 6 months
* HBeAg+ CHB pregnant women
* gestational age between 30-32 weeks
* HBV DNA \> 6 log10 copies/mL (or \>200,000 IU/mL)
* both mother and father of the child are willing to consent for the study

Major Exclusion Criteria:

* co-infection with hepatitis A, C, D, E, HIV-1 or sexually transmitted disease (STD)
* decompensated liver disease or significant co-morbidity
* history of abortion, or diagnosis of fetal defect, or congenital malformation in prior pregnancy
* antiviral used within six months prior to this pregnancy, or history of renal or tubular function impairment due to adefovir.
* requirement for other medication during pregnancy to manage other chronic disease(s) or concurrent treatment with immune-modulators, cytotoxic drugs, or steroids
* the biological father of the child had CHB
* clinical signs of threatened miscarriage in early pregnancy
* evidence of hepatocellular carcinoma
* maternal alanine aminotransferase (ALT) \> or = 5 x upper limit of normal (U/mL), or Total Bilirubin \> or = 2, or glomerular filtration rate (GFR) \< 100, or Albumin \< 25 g/L
* evidence of fetal deformity by ultrasound examination
* patient is participating other clinical study
C: Key Inclusion Criteria:

* Estimated glomerular filtration rate ≥ 50 mL/min (≥ 0.83 mL/sec).
* Currently receiving an antiretroviral regimen of DTG + ABC/3TC, or ABC/DTG/3TC FDC for ≥ 3 months prior to the screening visit.
* HIV ribonucleic acid (RNA) \< 50 copies/mL at the screening visit.
* Currently on a stable regimen for ≥ 3 months preceding the screening visit with documented plasma HIV-1 RNA \< 50 copies/mL for ≥ 3 months preceding the screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL).
* Have no documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV), DTG, ABC or 3TC.

Key Exclusion Criteria:

* Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance.
* Active tuberculosis infection.
* Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).
* Females who are pregnant.
* Females who are breastfeeding.
* Acute hepatitis in the 30 days prior to study entry.
* Chronic Hepatitis B Virus (HBV) infection.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
D: Note: As of 08/10/07, the arm assignments for current and new participants have changed. Please see the above description for this trial for more information.

Inclusion Criteria for Mothers:

* 18 years of age or older
* HIV infected
* In third trimester of pregnancy, or at most 3 days post-delivery
* If baby is not yet born, planning to deliver at a facility where the study is being conducted
* Plan to breastfeed

Exclusion Criteria for Mothers:

* Complications with this pregnancy
* Serious medical condition that would interfere with the study (e.g., that would prevent breastfeeding or adherence to the follow-up schedule), as judged by the on-site clinician

Inclusion Criteria for Infants:

* Born to an HIV infected mother who is eligible for the study
* Weighed at least 2000 grams (4.4 lbs) at birth
* Blood sample obtained from the infant for HIV-1 DNA PCR, CBC with differential, and ALT
* Infants in a multiple birth are eligible only if both/all infants are eligible for the study and assigned to the same study group
* Able to breastfeed (e.g., mother and infant alive with no condition apparent that would prevent breastfeeding)

Exclusion Criteria for Infants:

* HIV DNA PCR positive at birth
* ALT of Grade 2 or higher at birth
* Hemoglobin, absolute neutrophil count, or platelet count of Grade 3 or higher at birth
* Skin rash of Grade 2B (urticaria), Grade 3, or above
* Confirmed or suspected clinical hepatitis
* Serious illness or condition that would interfere with compliance with study procedures

Answer: C