Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase IV, Randomised, Multicentre, Double-blind, Study to Evaluate the Clinical Utility of Prospective Genetic Screening (HLA-B*5701) for Susceptibility to Abacavir Hypersensitivity
Brief Summary: Study to evaluate the utility of prospective HLA-B\*5701 screening on the incidence of abacavir hypersensitivity (ABC HSR) in 1800 previously ABC-naive adults with HIV-1 from Europe, Australia and other countries as applicable. The study has two (co-primary) objectives: i) to determine if screening for HLA-B\*5701 prior to ABC-containing HAART results in a lower incidence of clinically-suspected HSR versus current standard of care (no genetic screening) and ii) to determine if screening for HLA-B\*5701 prior to ABC-containing HAART, results in a significantly lower incidence of immunologically-confirmed HSR versus current standard of care (no genetic screening or patch testing). The study consists of up to a 28-day screening period, a randomised observation period (Day 1 through Week 6) and, for subjects experiencing a suspected ABC HSR and a subset of ABC-tolerant subjects, an epicutaneous patch test (EPT) assessment period. Eligible subjects will be randomised to one of two study arms: a Current Standard of Care Arm (no prospective genetic screening: Control) and a Genetic Screening Arm (prospective genetic screening). Subjects identified as HLA-B\*5701 positive in the prospective Genetic Screening Arm will not receive ABC and will be excluded from further study. Subjects who experience suspected ABC HSR during the 6-week observation will be withdrawn from ABC-containing product and undergo EPT patch testing 6 weeks later.


Options:
A: Arm Label: PGx-treatment; Type: EXPERIMENTAL; Interventions: Drug: Isoniazid | Arm Label: STD-treatment; Type: ACTIVE_COMPARATOR; Interventions: Drug: isoniazed | Intervention Type: DRUG; Name: Isoniazid; Assigned to Arm(s): PGx-treatment | Intervention Type: DRUG; Name: isoniazed; Assigned to Arm(s): STD-treatment
B: Arm Label: BIBW 2992; Type: EXPERIMENTAL; Interventions: Drug: BIBW 2992 | Arm Label: Cisplatin/Pemetrexed; Type: ACTIVE_COMPARATOR; Interventions: Drug: Pemetrexed, Drug: Cisplatin | Intervention Type: DRUG; Name: Pemetrexed; Assigned to Arm(s): Cisplatin/Pemetrexed | Intervention Type: DRUG; Name: BIBW 2992; Assigned to Arm(s): BIBW 2992 | Intervention Type: DRUG; Name: Cisplatin; Assigned to Arm(s): Cisplatin/Pemetrexed
C: Arm Label: non taxane based chemotherapy; Type: ACTIVE_COMPARATOR; Interventions: Biological: filgrastim, Drug: cyclophosphamide, Drug: epirubicin hydrochloride, Drug: fluorouracil, Genetic: microarray analysis, Other: immunohistochemistry staining method, Other: laboratory biomarker analysis, Procedure: biopsy, Procedure: conventional surgery, Procedure: neoadjuvant therapy, Radiation: radiation therapy | Arm Label: taxane based chemotherapy; Type: EXPERIMENTAL; Interventions: Drug: docetaxel, Drug: epirubicin hydrochloride, Genetic: microarray analysis, Other: immunohistochemistry staining method, Other: laboratory biomarker analysis, Procedure: biopsy, Procedure: conventional surgery, Procedure: neoadjuvant therapy, Radiation: radiation therapy | Intervention Type: BIOLOGICAL; Name: filgrastim; Assigned to Arm(s): non taxane based chemotherapy | Intervention Type: DRUG; Name: cyclophosphamide; Assigned to Arm(s): non taxane based chemotherapy | Intervention Type: DRUG; Name: docetaxel; Assigned to Arm(s): taxane based chemotherapy | Intervention Type: DRUG; Name: epirubicin hydrochloride; Assigned to Arm(s): non taxane based chemotherapy, taxane based chemotherapy | Intervention Type: DRUG; Name: fluorouracil; Assigned to Arm(s): non taxane based chemotherapy | Intervention Type: GENETIC; Name: microarray analysis; Assigned to Arm(s): non taxane based chemotherapy, taxane based chemotherapy | Intervention Type: OTHER; Name: immunohistochemistry staining method; Assigned to Arm(s): non taxane based chemotherapy, taxane based chemotherapy | Intervention Type: OTHER; Name: laboratory biomarker analysis; Assigned to Arm(s): non taxane based chemotherapy, taxane based chemotherapy | Intervention Type: PROCEDURE; Name: biopsy; Assigned to Arm(s): non taxane based chemotherapy, taxane based chemotherapy | Intervention Type: PROCEDURE; Name: conventional surgery; Assigned to Arm(s): non taxane based chemotherapy, taxane based chemotherapy | Intervention Type: PROCEDURE; Name: neoadjuvant therapy; Assigned to Arm(s): non taxane based chemotherapy, taxane based chemotherapy | Intervention Type: RADIATION; Name: radiation therapy; Assigned to Arm(s): non taxane based chemotherapy, taxane based chemotherapy
D: Intervention Type: DRUG; Name: Abacavir; Assigned to Arm(s): N/A

Answer: D