This proposal is to establish an AIDS research Clinical Trials Unit (CTU) at the Botswana-Harvard School of Public Health AIDS Initiative Partnership (BHP) in Botswana. The CTU would conduct a fully integrated program for conducting AIDS clinical trials in three programmatic areas: vaccines, therapy, and prevention research. These areas of emphasis would coincide with trials conducted by the HIV Vaccine Trials Network (HVTN), the Adult AIDS Clinical Trials Group (AACTG), and the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT). Trials are already conducted at BHP under the auspices of HVTN and AACTG. The Botswana CTU would include three Clinical Research Sites (CRSs). These would be: (1) the Gaborone-based HIV Vaccine Trial Unit (HVTU) CRS;(2) the Gaborone-based Prevention and Treatment Trial (PTT) CRS, which would do both prevention (IMPAACT) and treatment (AACTG) trials;and (3) the Molepolole-based Prevention and Treatment Trial (PTT) CRS which would also do both prevention (IMPAACT) and treatment (AACTG) trials. This organizational structure is designated as such because vaccine trials would be done only in Gaborone, and the HVTU CRS facility is separate from the PTT CRS facility in Gaborone. The combined resources of the BHP have major expertise in clinical trial research, extensive facilities, and a large and diversified population of potential volunteers for the conduct of Phase I, Phase II, and Phase III trials. We plan to enroll at least 20 subjects in each of the three sites for each respective area of emphasis during the first six months of the award, and have already enrolled much larger numbers on an annual basis in all three areas. Procedures to assure ethical review, clinical oversight, informed consent, government and institutional approvals, and community relations are described. The proposed PI for the CTU, Dr. M. Essex, and the proposed heads for the three CRSs, Drs. T. Villafana, I. Thior, and W. Wester would provide both intellectual and administrative leadership. ADMINISTRATIVE COMPONENT:

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
Application #
Study Section
Special Emphasis Panel (ZAI1-TP-A (M2))
Program Officer
Welsch, Sue A
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Harvard University
Schools of Public Health
United States
Zip Code
Beneri, C A; Aaron, L; Kim, S et al. (2016) Understanding NIH clinical case definitions for pediatric intrathoracic TB by applying them to a clinical trial. Int J Tuberc Lung Dis 20:93-100
Fogel, Jessica M; Hudelson, Sarah E; Ou, San-San et al. (2016) Brief Report: HIV Drug Resistance in Adults Failing Early Antiretroviral Treatment: Results From the HIV Prevention Trials Network 052 Trial. J Acquir Immune Defic Syndr 72:304-9
Tuluc, Florin; Spitsin, Sergei; Tustin, Nancy B et al. (2016) Decreased PD-1 Expression on CD8 Lymphocyte Subsets and Increase in CD8 Tscm Cells in Children with HIV Receiving Raltegravir. AIDS Res Hum Retroviruses :
Borges, Álvaro H; Lundh, Andreas; Tendal, Britta et al. (2016) Nonnucleoside Reverse-transcriptase Inhibitor- vs Ritonavir-boosted Protease Inhibitor-based Regimens for Initial Treatment of HIV Infection: A Systematic Review and Metaanalysis of Randomized Trials. Clin Infect Dis 63:268-80
TenoRes Study Group (2016) Global epidemiology of drug resistance after failure of WHO recommended first-line regimens for adult HIV-1 infection: a multicentre retrospective cohort study. Lancet Infect Dis 16:565-75
Cohen, Myron S; Chen, Ying Q; McCauley, Marybeth et al. (2016) Antiretroviral Therapy for the Prevention of HIV-1 Transmission. N Engl J Med 375:830-9
Luetkemeyer, Anne F; Rosenkranz, Susan L; Lu, Darlene et al. (2015) Combined effect of CYP2B6 and NAT2 genotype on plasma efavirenz exposure during rifampin-based antituberculosis therapy in the STRIDE study. Clin Infect Dis 60:1860-3
Rizk, Matthew L; Du, Lihong; Bennetto-Hood, Chantelle et al. (2015) Population pharmacokinetic analysis of raltegravir pediatric formulations in HIV-infected children 4 weeks to 18 years of age. J Clin Pharmacol 55:748-56
Podany, Anthony T; Bao, Yajing; Swindells, Susan et al. (2015) Efavirenz Pharmacokinetics and Pharmacodynamics in HIV-Infected Persons Receiving Rifapentine and Isoniazid for Tuberculosis Prevention. Clin Infect Dis 61:1322-7
Nachman, Sharon; Alvero, Carmelita; Acosta, Edward P et al. (2015) Pharmacokinetics and 48-Week Safety and Efficacy of Raltegravir for Oral Suspension in Human Immunodeficiency Virus Type-1-Infected Children 4 Weeks to 2 Years of Age. J Pediatric Infect Dis Soc 4:e76-83

Showing the most recent 10 out of 27 publications