Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: ARVs to Prevent Breastmilk HIV:Viral and Immune Responses
Brief Summary: Identifying new approaches for preventing breastmilk transmission of HIV-1 is an important research priority. To this end, clinical trials are underway to evaluate the efficacy of HAART (zidovudine, lamivudine, nevirapine) during late pregnancy/lactation versus zidovudine/nevirapine peripartum for prevention of breastmilk HIV-1 transmission. It is important to understand the mechanism of effect of these antiretroviral (ARV) strategies on prevention of breastmilk HIV-1 transmission.

This phase II trial will compare HAART vs peripartum zidovudine/nevirapine for effect on breastmilk HIV-1, breastmilk HIV-1 specific immune responses, and infant HIV-1 specific immune responses.

100 pregnant HIV-1 seropositive women in Nairobi with CD4 counts between 200 to 500 who have chosen to breastfeed will receive either ARV regimen. Mother-infant pairs will be followed for 1 year after delivery. Home visits will be conducted in the first month (\~10 visits) to collect 2-5 mls of breastmilk per visit. Mother-infant pairs will be seen in the study clinic with maternal blood and breastmilk and infant blood collected at months 1, 3, and 6 for HIV-1 and HIV-1 Elispot assays. Breastmilk HIV-1 RNA and DNA levels will be quantified in Dr. Overbaugh's laboratory in Seattle and Elispot assays conducted in Nairobi with validation of a subset in Dr. Rowland-Jones laboratory in Oxford. Viral loads, decay curves, half-life, and re-population following ARV cessation will be estimated for each regimen and regimens compared. These studies will provide insight into the viral and immune responses to ARV regimens proposed for prevention of breastfeeding HIV-1 transmission and will be important for rational design of future interventions. After taking into account, estimated loss to follow-up, the targeted sample size with outcome data was 80 women, 40 in each trial arm, estimating undetectable breast milk HIV-1 RNA levels in the HAART arm and median breast milk HIV-1 RNA levels of 3.0 log10 in women receiving ZDV/NVP.


Options:
A: Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nevirapine, Drug: AZT, Drug: NVP and AZT | Arm Label: C; Type: EXPERIMENTAL; Interventions: Drug: Nevirapine, Drug: AZT, Drug: NVP+AZT | Arm Label: B; Type: EXPERIMENTAL; Interventions: Drug: Nevirapine, Drug: NVP | Intervention Type: DRUG; Name: Nevirapine; Assigned to Arm(s): A, B, C | Intervention Type: DRUG; Name: AZT; Assigned to Arm(s): A, C | Intervention Type: DRUG; Name: NVP and AZT; Assigned to Arm(s): A | Intervention Type: DRUG; Name: NVP; Assigned to Arm(s): B | Intervention Type: DRUG; Name: NVP+AZT; Assigned to Arm(s): C
B: Arm Label: Abrupt Weaning; Type: EXPERIMENTAL; Interventions: Other: abrupt weaning at 4 months | Arm Label: Exclusive breastfeeding per WHO guidelines; Type: ACTIVE_COMPARATOR; Interventions: Other: Continued exclusive breastfeeding | Intervention Type: OTHER; Name: abrupt weaning at 4 months; Assigned to Arm(s): Abrupt Weaning | Intervention Type: OTHER; Name: Continued exclusive breastfeeding; Assigned to Arm(s): Exclusive breastfeeding per WHO guidelines
C: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nevirapine and mulitvitamins | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Nevirapine and mulitvitamins | Intervention Type: DRUG; Name: Nevirapine and mulitvitamins; Assigned to Arm(s): 1, 2
D: Arm Label: B; Type: ACTIVE_COMPARATOR; Interventions: Drug: Combined short-course zidovudine/nevirapine | Arm Label: A; Type: EXPERIMENTAL; Interventions: Drug: HAART | Intervention Type: DRUG; Name: Combined short-course zidovudine/nevirapine; Assigned to Arm(s): B | Intervention Type: DRUG; Name: HAART; Assigned to Arm(s): A

Answer: D