CROI 2015 Program and Abstracts

Abstract Listing

Poster Abstracts

TUESDAY, FEBRUARY 24, 2015 Session P-R7 Poster Session

Poster Hall

2:30 pm– 4:00 pm Opportunistic Infections: Odds and End Organs 843 The Exposure and Geospatial Risk Factors for AIDS-Associated Penicilliosis in Vietnam Thuy Le 1 ; Brian Jonat 2 ; NgoT. Cuc 3 ; NguyenT.Thanh 1 ; DangT. Bich 4 ; Cecilia Shikuma 5 ; Jeremy Day 1 ; HeimanWertheim 1 ; Jeremy Farrar 1 ; MarcelWolbers 1 1 Oxford University Clinical Research Unit, Ho Chi Minh City, Viet Nam; 2 New York-Presbyterian University Hospital of Columbia and Cornell, New York City, NY, US; 3 Hospital for Tropical Diseases, Ho Chi Minh City, Viet Nam; 4 National Hospital for Tropical Diseases, Hanoi, Viet Nam; 5 Hawaii Center for AIDS, University of Hawaii, Ho Chi Minh, Viet Nam Background: Penicilliosis is an important opportunistic fungal infection in residents and travelers to Southeast Asia, China and India. Incidence increases during the rainy months and is associated with humidity and soil exposure. Bamboo rats are the only non-human host; however, evidence for zoonotic transmission is lacking, and disease reservoir and transmission risk remain unknown. Methods: We conducted a case-control study to evaluate the exposure, behavioral, and geospatial risk factors for penicilliosis in 205 HIV-infected patients with incident penicilliosis and 406 control patients with AIDS but without pencilliosis. Cases and controls were matched for host susceptibility, which included age, sex, CD4 count or stage IV disease. Patients were recruited from the two largest referral centers for HIV care in northern and southern Vietnam. Conditional logistic regression analyses were used to evaluate the following risk categories for disease: injection drug use, antiretroviral therapy (ART), antifungal prophylaxis, cigarette smoking, outdoor occupation, proximity/exposure to bamboo rats, water, soil, tropical plants, highland plants, farming animals, domestic animals, and raw animal products. Geospatial risk was evaluated using global positioning mapping of patients’ residence. Results: 75%were male. Median age was 34 (IQR: 31 – 38) years. Median CD4 count was 16 (IQR: 7.0- 36.0) cells/ m L. In the multivariate analysis, patients with proximity or occupational exposure to tropical plants (bamboo, sugar cane, and/or rice) and patients with occupational exposure to farming animals were at increased risk for penicilliosis, OR 1.84 (95% CI: 1.17-2.90), p=0.00841 and OR 2.03 (95% CI: 1.18-3.49), P=0.01007, respectively. In the univariate analysis, not being on ART, outdoor occupation, proximity/exposure to tropical plants, and exposure to farming animals were statistically significant risk factors for disease. Cases were geospatially distributed in southern Vietnam at provincial level. Comparing to controls, cases appeared to concentrate in the central highlands and its adjacent provinces north of Ho Chi Minh City. Conclusions: Our data provided the first evidence for geospatial risk of penicilliosis in the endemic region. The identification of the highlands as disease hot spots suggested an ecological relationship between bamboo rats as an animal reservoir and a potential environmental reservoir in tropical plants and animal farming. 844 A5265 Clinical Trial: Gentian Violet for Oral Candidiasis is as Effective as Nystatin Pranab K. Mukherjee 1 ; Lauren Patton 2 ; James Hakim 4 ; Huichao Chen 3 ; MaiT. Pho 5 ; Kenneth A. Freedberg 6 ; Caroline Shiboski 7 ; Mahmoud A. Ghannoum 1 ; Robert A. Salata 1 Oral HIV/AIDS Research Alliance (OHARA)/ACTG 1 Case Western Reserve University, Cleveland, OH, US; 2 University of North Carolina, Chapel Hill, NC, US; 3 Harvard School of Public Health, Boston, MA, US; 4 University of Zimbabwe - Parirenyatwa, Harare, Zimbabwe; 5 University of Chicago, Chiago, IL, US; 6 Harvard Medical School, Boston, MA, US; 7 University of California San Francisco (UCSF), San Francisco, CA, US Background: Oral candidiasis (OC) is a common infection in HIV-infected patients (HIVIP), especially in resource-limited settings (RLS), and is commonly treated with nystatin (NYS). We report the results of A5265, a randomized clinical trial (RCT) comparing the efficacy of gentian violet (GV) vs. NYS in the treatment of OC in HIVIP. Methods: A5265 was a multicenter, open-label, assessment-blinded RCT in RLS sites to compare the safety & efficacy of topical GV to that of oral NYS suspension (enrollment target = 494 patients). Adult HIV-infected patients [stratified by CD4 cell counts (> or ≤ 200 cells/mm 3 )] were randomized to receive either GV (0.00165%, BID) or NYS (500,000 units, QID) for 14 d. OC signs & symptoms were evaluated in a treatment-blinded manner. The study was stopped on 10/19/12 due to mortality unrelated to study drugs. 221 subjects were enrolled, and final results are presented. Primary endpoint: cure or improvement (reduction in severity ≥ 25%). Secondary endpoints (SEPs): cure, clinical improvement, symptoms (discomfort and pain), yeast colony counts, adverse events (AEs), tolerance, adherence, quality of life, acceptability, and cost per treatment course (CPTC). Repeated confidence intervals (CIs) were used to control type I error of 0.05 (99.7% and 95.1% CI for interim and final analyses, respectively). Results: 202 patients were eligible for analysis (GV, n=100; NYS, n=102). 76 (76%) in the GV arm had cure or improvement of OC compared to 73 (71.6%) in the NYS arm, resulting in a non-significant (NS) difference in clinical efficacy rates (GV-NYS) of 0.044 (CI = -0.077, 0.166). Efficacy of GV was significantly higher than that of NYS when stratified by CD4 count (>200 cells/mL; CI = 0.02, 0.36). No GV-related AEs were noted. Pain was significantly lower in GV than in NYS arm at relapse ( P = 0.03). 61% and 39% of participants in GV arm had no or mild-to-moderate staining, respectively. No significant difference was found between the two arms in efficacy rates or any other SEPs. CPTC of GV ranged from US $0.38 to $3.15, while that of NYS ranged from $6.25 to $37.48. The NS results could be due to lower enrollment. However, within the reduced sample size limitation of the study, the results were in favor of GV. Conclusions: We found that GV is as effective as, and less costly than, NYS in the treatment of OC in the HIV-setting, and may thus provide an inexpensive alternative in RLS countries. 845 Effective Treatment of Lymphogranuloma Venereum (LGV )W ith 1g Azithromycin AdministeredWeekly for 3Weeks in an HIV-Infected Population José L. Blanco ; Irene Fuertes; Jordi Bosch; Ana Gonzalez; AndreaVergara; Rob Camp; Esteban Martinez;Teresa Estrach; Josep M. Gatell; Merçe Alsina Hospital Clinic, Barcelona, Barcelona, Spain Background: Lymphogranuloma venereum (LGV) is an ulcerative and invasive sexually transmitted disease (STD) caused by Chlamydia trachomatis Serovar L1, L2, or L3. LGV has become hyperendemic among men who have sex with men (MSM) in Western Europe. Doxycycline (100 mg orally twice daily for 3 weeks, DoxLGV) has long been the regimen of choice because there are no controlled trials supporting alternative treatments. Even though azithromycin (1 g orally once weekly for 3 weeks, prolonged azithromycin regimen, PAzR) is likely to be effective against LGV, limited data are available on the clinical effectiveness of this antibiotic in the treatment of LGV. We aimed to evaluate treatment with oral PAzR in patients presenting with rectal LGV infection. Methods: A longitudinal prospective study at the STD Unit in the Hospital Clinic was conducted in Barcelona between 6/2010 and 4/2014. Adult patients were eligible for inclusion if they presented with clinical manifestation of anorectal syndrome or any clinical suspicion of LGV infection after recent history of unsafe sex. All patients received a single dose of 1 gr intramuscular ceftriaxone but were aleatorily assigned to receive, If LGV was detected, at visit 1 (day +7): (i) oral doxycycline 100 mg twice a day for 3 weeks; or (ii) azithromycin 1 g orally once weekly for 3 weeks. All participants were clinically assessed and those in the PAzR group were also assessed weekly by real-time multiplex polymerase chain reaction (M-PCR) that includes LGV (visit 2, day +14; visit 3, day +21; visit 4/end of study, day +28).

Poster Abstracts

511

CROI 2015