Breastfeeding Antiretroviral And Nutrition Study (BAN Study)
In the BAN study, women from PMTCT programs at four antenatal care clinics in Lilongwe were recruited to evaluate the efficacy of extended antiretroviral treatment, a nutritional intervention, and exclusive breastfeeding. 2370 women and their infants were enrolled between 2004-2009. The primary results demonstrated either maternal HAART or infant nevirapine for 28 weeks are effective in reducing HIV-1 transmission during breastfeeding. Among 2370 mother-infant pairs, 5.0% of infants were HIV-1-infected at 2 weeks of life. The estimated risk of HIV-1 transmission between 2 and 28 weeks was higher in the control arm (5.9%, referent) compared to either of the ARV arms (3.0% in maternal HAART arm [p=0.0096]; 1.6% in infant nevirapine arm [p<0.0001]). The estimated risk of infant HIV-1 infection or death was 7.0% in the control arm, 4.4% in the maternal HAART arm (p=0.04), and 2.4% in the infant nevirapine arm (p<0.0001). Although the study was not powered to compare the two intervention arms, there was some suggestion that infant nevirapine offered greater improvement in HIV-1-free survival (p=0.03).
Nevirapine Resistance Sub–study
The nevirapine resistance sub-study compared the prevalence of NVP-resistant virus in women who took single dose NVP plus combivir for 7 days post-partum and women who only took a single dose of NVP at delivery. The results showed the addition of 7 days of ZDV+3TC to sdNVP at labor significantly reduced viral resistance to NVP detectable in plasma and breast milk at 2 and 6 weeks postpartum.
HPTN 035 Microbicide Study
The HPTN 035 Microbicide Study was a four-arm, double blinded placebo controlled randomized study to determine if the consistent use of vaginal microbicide with each sexual act could reduce the male to female transmission of HIV. Two new microbicidal agents (BufferGel and Pro2000 Gel) were tested. Across all study sites 3099 women were followed for an average of 20.4 months with 93.6% retention and 81.1% self-reported gel adherence. Adverse event rates were similar in the four study arms. HIV incidence rates in the 0.5% PRO2000 Gel, BufferGel, Placebo Gel and No Gel arms were 2.70, 4.14, 3.91 and 4.02 per 100 women-years, respectively. 0.5% PRO2000 Gel reduced HIV acquisition in women by 30% but this did not reach statistical significance. BufferGel did not alter the risk of HIV infection. Both products were safe.
Microbicides Acceptability 035 Sub–study
The objective of this study was to identify and explore, from a variety of perspectives, the relationships among factors affecting acceptability and use of microbicides being studied in HPTN 035. The study enrolled and interviewed a core group of female participants, male partners, health professionals, and community stakeholders.
KCH Microbiology Study
This study enrolled patients from June 2006 to December 2007 to determine the etiology and drug susceptibility patterns of infections in KCH patients. During the study period specimens were submitted from 2,351 patients about half of whom were seen on the medical service. Microbiologic cultures were done on clinical specimens as follows: 1980 on blood, 146 on cerebrospinal fluid, 196 on abscesses, 59 on joint fluids and 12 on bone. A total of 406 bacteria and 12 fungi were isolated from the specimens and antimicrobial susceptibility was determined. Molecular analysis will be performed on Staphylococcus aureus isolates.
The objective of the study was to determine whether seeing advanced HIV patients more often through home visits with trained community advocates and nurses and providing nutritional support with enhanced clinical care when they start antiretroviral therapy would decrease mortality. This study enrolled patients at the highest risk for death and each client received nutritional supplementation, weekly HBC visits by nurses, guardian education, trained community volunteer visits and as needed clinician visits in addition to ART, CPT, and multivitamins. Despite the interventions, the mortality of these patients remained high with only 50% of the patients surviving to the six month follow-up time point. The primary cause of death was cryptococcal meningitis with six patients succumbing to this infection with possible immune reconstitution playing a role.