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Abstract not available
Researchers
Alfred Sommer
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HPTN 052 is a Phase III, two-arm, multi-site, randomized trial to determine the effectiveness of two treatment strategies in preventing the sexual transmission of HIV in HIV-serodiscordant couples.
Based on data collected in Africa and Thailand, there is a correlation between HIV viral load (blood levels) and HIV transmission. Specifically, the higher the viral load in the blood, the more likely the chance for transmission. Antiretroviral therapy (ART) reduces the viral load in the blood, as well as in genital secretions (for both men and women), and the drugs can be detected in semen and vaginal and cervical secretions. All of this information strongly suggests that ART may make HIV-infected people less contagious. HPTN 052 compares the HIV-infection rates of two groups of HIV-serodiscordant couples. The index case of the first group starts taking ART as soon as the couple is enrolled in the study, while the index case of the second group starts taking ART when his or her CD4+ cell count drops to 200 cells/mm3 or when he or she develops an AIDS-defining illness. Both groups will receive HIV primary care and couples counseling sessions to teach them how to reduce their risk of transmission.
Researchers
Robert Bollinger Jr.
David Celentano
Joel Gallant
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Dr. Eshleman currently serves as Head of the Virology Core of this international HIV Prevention Network. A proposal to continue funding of this network is under consideration at the NIH. If continued funding for the HPTN is approved, Dr. Eshleman would serve as PI of the HPTN Network Laboratory, as well as Director of the HPTN Virology Core. Dr. Eshleman currently serves as Virologist/HPTN Central Lab. Rep. for HIVNET 012 and 023, and for HPTN 046, 050, 052, 057, 059. Her participation in those trials will continue, even if some of the trials are administratively transferred to other networks (e.g. IMPAACT or MTN).
Researchers
Susan Eshleman
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Chlamydia trachomatis is the most common sexually transmitted bacterial pathogen in the world, causing serious adverse events on womens reproductive health including complications of pregnancy, pelvic inflammatory disease and infertility. The objectives of this project are to define the epidemiology, risk factors, transmission kinetics, and pathogenesis of C. trachomatis infections in different population settings and in different disease states. In a multi-center international trial of 5,000 participants, we screened for a variety of STDs using non-invasive molecular amplified assays. Prevalence of chlamydia in young women was 12.2% in China, 0.1% in India, 6.4% in Peru, 10.4% in Russia, and 2.5% in Zimbabwe. Gonorrhea prevalence was < 1.5% in all five countries. Serologic evidence for HSV-2 infection ranged from 9 to 20% among women in all countries except Zimbabwe, where the prevalence among women was 59%. These data have important implications for the future of the HIV epidemics because of the strong association of STDs, particularly HSV-2, for HIV acquisition. In a study screening high school students in Baltimore the overall prevalence for chlamydia was 18.1% of 957 students. Of those who tested positive for C. trachomatis the re-infection rate was 25.9%. In conducting several cost-effectiveness analyses, we demonstrated that self-obtained vaginal swabs for nucleic acid amplification assays were the most cost effective method for preventing pelvic inflammatory disease. Vaginal specimen collection also received the highest preference rating by women. Screening high-risk men with partner notification also prevented more PID and was less costly than expanded screening for women. We also we conducted a cost effectiveness study which modeled cost-effectiveness models analyses for screening males for chlamydia who were entering the National Job Core Training Program. It demonstrated that screening men in this venue prevented disease sequelae in current female partners, as well as future female partners. We have used the Internet to offer sampling for chlamydia for >1300 women at home using self-obtained vaginal swabs. Over 90% preferred to collect their own sample, with 96.7% indicating the collection was easy/very easy. Prevalence has been 15.3% in young women age 15-19 yr. Both young age and Black race were statistically associated with chlamydia positivity. We have extended Internet screening to males with self-collected penile swabs and urines. Overall, the chlamydia prevalence was 13.5% and 22.6% in men 15-19 yr. This unique public health strategy can help reach persons, who do not have insurance, prefer confidentiality and privacy, and who do not have a family doctor. We have documented a decrease in the prevalence of both chlamydia and gonorrhea in an out reach program for pregnant women in Baltimore. At the beginning of the screening program, the prevalence of chlamydia was 18.2% but declined over the subsequent years to 8.7% in 2008. The prevalence of gonorrhea also declined significantly from a high of 9.1% to a low of 1.3% in 2008. Continuation of outreach screening and treatment programs can help reduce the prevalence of STDs in our community. We participated in surgical and antibiotic treatment intervention studies in Ethiopia, Niger, and Tanzania in efforts to control trachoma, the most common infectious cause of blindness worldwide. These studies have shown dramatic reductions in blindness in communities in which severe disease is first treated with surgery followed by community-wide azithromycin mass therapy. To determine whether infection recurs, we re-examined individuals in Tanzania five years after initiation of the program. Treatment coverage was 80% for all ages in the first year, although coverage 18 months later was lower at < 70%. At five years, clinical trachoma rates were still lower than at baseline, ranging from 45% compared to 81% at baseline. Chlamydia infection rates at baseline were 71%, but declined to 27% five years after two rounds of mass therapy. Further studies are planned to access the ancillary effects of mass azithromycin therapy on other diseases, such as urogenital chlamydia and gonorrhea infections, diarrhea, acute respiratory diseases and malaria.
Researchers
Charlotte Gaydos
Thomas Quinn
Anne Rompalo
Sheila West
Jonathan Zenilman
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This is a randomized controlled study of a community-based model of HIV voluntary counseling and testing. It is conducted in Thailand, Tanzania, Zimbabwe, and South Africa.
Researchers
Katherine Fritz
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Highly active antiretroviral therapy (HAART) has reduced morbidity and mortality in HIV-infected persons worldwide. However, early treatment failure (i.e. WHO stage 3 or 4 illnesses or death during the first 12 months of HAART) is >3-fold higher in resource limited settings (RLS) than in resource-rich settings. Early treatment failure is associated with low CD4 count, low body mass index, and anemia, but these markers are nonspecific and could reflect advanced HIV, co-infections, and/or malnutrition. The relative contribution of malnutrition to early treatment failure in RLS is unknown. Up to 40% of adults in RLS are malnourished due to protein-energy, iron or iron-deficiency anemia, or other micronutrient deficiencies, which are associated with immune dysfunction and increased morbidity and mortality. However, the significance of this malnutrition in HIV-infected persons initiating HAART in RLS is unclear. In addition to immune dysfunction, this malnutrition has been associated with impaired gut integrity, increased microbial translocation and immune activation. Recently, chronic HIV infection
has also been associated with a “leaky gut” and systemic immune activation. High levels of immune activation result in impaired immune restoration with HAART and HIV disease progression. Therefore, we hypothesize that baseline malnutrition is predictive of early treatment failure among HIV-infected adults in RLS and that early treatment failure is related to the synergistic deleterious effects of HIV and malnutrition on gut mucosal integrity leading to increased systemic immune activation. To address our hypotheses, we will utilize data and cryopreserved samples collected as part of an ongoing trial conducted by the Adults AIDS Clinical Trial Group (ACTG 5175). This NIH-funded study is evaluating the efficacy of HAART among 1571 HIV-infected adults in 8
RLS countries (Africa-3, Asia-2, Americas-3) and the United States. We propose three specific aims:1) To characterize baseline micronutrient status and assess its relationship to baseline disease stage, demographics and simple-to-measure nutritional indices among treatment-naïve HIV-infected adults initiating HAART; 2) To assess whether specific measures of baseline malnutrition are independent predictors of early treatment failure. 3) To determine whether malnutrition and treatment failure are associated with microbial translocation, immune activation, and reduced immune restoration. Our study has a high likelihood of success because our international
team includes leaders in HIV, immunology, statistics and nutrition research. Data and specimens for our study come from a NIH-funded trial that is ongoing but has completed enrolment. This will reduce the time needed to complete the planned studies and optimize cost-efficiency. Importantly, data generated from our study will fill a
critical knowledge gap in the understanding the role of malnutrition on early HAART outcomes in RLS. Such data are needed to 1) provide necessary evidence to guide the design of new trials that will optimize the benefits of HAART in RLS, where HIV, early treatment failure, food insecurity, and malnutrition are all common, and 2) further our insights on the relationship between malnutrition, immunity and infectious disease pathogenesis.
Researchers
Adriana Andrade
Robert Bollinger Jr.
Parul Christian
Amita Gupta
David Thomas
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