Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Phase III Randomized Placebo-Controlled Trial of HSV-2 Suppression to Prevent HIV Transmission Among HIV-Discordant Couples
Brief Summary: The University of Washington has received funding to conduct a proof-of-concept trial to assess the impact of suppression of genital herpes on HIV infectiousness. This study (the Partners in Prevention Study) will enroll HIV discordant heterosexual couples in which the HIV-infected partner is co-infected with herpes simplex virus type 2 (HSV-2) to test the efficacy of twice daily (bid) acyclovir (400 mg) given to the HIV-infected partner to prevent transmission to his/her HIV negative partner(s). This randomized, double-blind, placebo-controlled proof-of-concept trial will provide evidence for the efficacy of HSV-2 suppression with daily acyclovir on HIV transmission among HIV-discordant couples among whom the HIV-positive partner is also HSV-2 seropositive with CD4 \>250. The researchers hypothesis is that, by decreasing the frequency and amount of genital HIV shedding, standard doses of daily acyclovir 400 mg bid will reduce the rate of HIV transmission by 50% in HIV-discordant couples among whom the HIV-infected partner is HSV-2 positive.

Under the study protocol version 4.1.1, 3000 HIV-discordant heterosexual couples in which the HIV-positive partner is HSV-2 positive and has a CD4 count \>250 will be recruited; participants will be followed for up to 2 years. A 4% per year HIV incidence in the placebo arm is assumed.

The first study site began enrolling participants on 17 November 2005. As of September 2006, 14 sites in Eastern and Southern Africa had participated in recruiting the 2300 HIV-discordant couples enrolled to date.


Options:
A: Arm Label: 1 Standard Care (SC); Type: NO_INTERVENTION; Interventions: N/A | Arm Label: 2 Standard Care + Educational (SCE); Type: OTHER; Interventions: Behavioral: educational instruction in clinic | Arm Label: 3 Standard Care + Educational + Phone Calls (SCEP); Type: OTHER; Interventions: Behavioral: educational instruction and phone follow-up | Intervention Type: BEHAVIORAL; Name: educational instruction and phone follow-up; Assigned to Arm(s): 3 Standard Care + Educational + Phone Calls (SCEP) | Intervention Type: BEHAVIORAL; Name: educational instruction in clinic; Assigned to Arm(s): 2 Standard Care + Educational (SCE)
B: Intervention Type: BEHAVIORAL; Name: User-independent contraception program; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: Future Planning Perspectives program; Assigned to Arm(s): N/A
C: Arm Label: Treatment; Type: EXPERIMENTAL; Interventions: Behavioral: follow-up phone counseling | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: follow-up phone counseling; Assigned to Arm(s): Treatment
D: Arm Label: Acyclovir; Type: ACTIVE_COMPARATOR; Interventions: Drug: Generic acyclovir | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Generic acyclovir; Assigned to Arm(s): Acyclovir | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: D