Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Phase 3, Multi-center, Double-blind, Randomized, Placebo-controlled Effectiveness and Safety Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women
Brief Summary: This Phase III, double-blind, randomized, placebo-controlled trial enrolled HIV-negative women from 4 sites in 3 countries (Kenya, Tanzania, South Africa). The study's purpose was to investigate the safety and effectiveness of a once-daily Truvada® pill (compared with placebo) in preventing HIV among HIV-uninfected women at risk of becoming infected through sexual intercourse.

The study population included HIV-antibody-negative women between the ages of 18-35 who were at risk of HIV acquisition through sexual intercourse. Each participant was randomized to take either a daily single oral tablet of Truvada®, which is a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg), or an identical placebo.

After enrollment, each participant was followed every four weeks. All participants were followed for an additional eight weeks after study drug was stopped. Incidence rates of HIV infection were compared between the two groups (active drug and placebo) using the intent-to-treat principle.


Options:
A: Arm Label: TDF/FTC; Type: EXPERIMENTAL; Interventions: Drug: daily TDF/FTC | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: daily TDF/FTC; Assigned to Arm(s): TDF/FTC | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Tenofovir Disoproxil Fumarate (TDF); Type: ACTIVE_COMPARATOR; Interventions: Drug: Tenofovir Disoproxil Fumarate (TDF) | Arm Label: Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF); Type: ACTIVE_COMPARATOR; Interventions: Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Tenofovir Disoproxil Fumarate (TDF); Assigned to Arm(s): Tenofovir Disoproxil Fumarate (TDF) | Intervention Type: DRUG; Name: Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF); Assigned to Arm(s): Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: TDF-FTC,condoms,adh/risk counseling; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg | Arm Label: Placebo,condoms,adh/risk counseling; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo Oral Tablet | Intervention Type: DRUG; Name: Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg; Assigned to Arm(s): TDF-FTC,condoms,adh/risk counseling | Intervention Type: DRUG; Name: Placebo Oral Tablet; Assigned to Arm(s): Placebo,condoms,adh/risk counseling
D: Arm Label: Truvada Arm; Type: EXPERIMENTAL; Interventions: Drug: Truvada | Arm Label: Placebo Arm; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: Truvada; Assigned to Arm(s): Truvada Arm | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo Arm

Answer: D