Table 1.
Case studies: Standard of Care in comparator arms in clinical trials
| Name of trial | Intervention/ condition |
Status quo SOC at trial initiation | Control arm(s) | Investigational arm(s) | Findings/ implications |
|---|---|---|---|---|---|
| A52083: | Optimal Combined Therapy After single dose nevirapine Exposure for the prevention of mother-to-child transmission (PMTCT) | 3TC/ZDV or FTC/TDF plus NVP | FTC/TDF + NVP | FTC/TDF + LPV/r | The LPV/r-containing arm was superior. Host countries adopted new treatment policies for women previously treated with sdNVP |
| A51755 | First line ARV regimens | 3TC/ZDV plus EFV or NVP | 3TC/ZDV + EFV | FTC/TDF + EFV ddI + FTC + ATV |
The TDF-containing regimens were equally effective and safer; the ddI/FTC/ATV regimen was inferior to the other two regimens. FTC/TDF + EFV was widely adopted as first line regimen |
| PEPI-Malawi10 SWEN7 HPTN 0469 | HIV prevention during breastfeeding for infants born to HIV-infected mothers | Official SOC recommendations changed during the conduct of trials. Formula feeding was recommended until excess mortality was detected, then early weaning and finally extended breast feeding was considered the best solution. No ARV breastfeeding interventions had been proven when PEPI was initiated. During the conduct of SWEN and HPTN 046, NVP prophylaxis was not implemented as SOC in any country | PEPI: placebo SWEN: placebo HPTN 046: placebo initially, trial modified to include 6 week NVP control arm after SWEN results became available |
PEPI: 12 weeks infant NVP SWEN: 6 weeks infant NVP HPTN 046: 6 months NVP |
All these interventions were designed to address HIV exposure during breastfeeding. In high-income countries, HIV-infected mothers use formula and do not breastfeed, but formula is not safe or feasible in RLS. Following release of the study results, infant NVP during breastfeeding was adopted in the WHO guidelines for PMTCT in 2009. |
Abbreviations:
SOC = Standard of Care
ARV = Antiretroviral
3TC = lamivudine
ddI = didanosine
FTC = emtricitabine
TDF = tenofovir
EFV =efavirenz
NVP = nevirapine
LPV/r = lopinavir/ritonavir