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1. Acceptability of a Dapivirine/Placebo Gel Administered Rectally to HIV-1 Seronegative Adults (MTN-026)

Author

Bauermeister, José A., Tingler, Ryan C., Dominguez, Clara, Dunne, Eileen F., Hoesley, Craig, Ho, Ken, Johnson, Sherri, Lucas, Jonathan, Macagna, Nicole, Brown, Elizabeth, Gundacker, Holly, Peda, Melissa, Jacobson, Cindy E., Kramzer, Lindsay, Singh, Devika, Dezzutti, Charlene S., Ayudhya, Ratiya Pamela Kunjara Na, Marzinke, Mark A., Piper, Jeanna, Devlin, Bríd, Nuttall, Jeremy, McGowan, Ian, Hendrix, Craig W., and Cranston, Ross D.

Published
2022
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2. Treatment with Commonly Used Antiretroviral Drugs Induces a Type I/III Interferon Signature in the Gut in the Absence of HIV Infection

Author

Hughes, Sean M., Levy, Claire N., Calienes, Fernanda L., Stekler, Joanne D., Pandey, Urvashi, Vojtech, Lucia, Berard, Alicia R., Birse, Kenzie, Noël-Romas, Laura, Richardson, Brian, Golden, Jackelyn B., Cartwright, Michael, Collier, Ann C., Stevens, Claire E., Curlin, Marcel E., Holtz, Timothy H., Mugo, Nelly, Irungu, Elizabeth, Katabira, Elly, Muwonge, Timothy, Lama, Javier R., Baeten, Jared M., Burgener, Adam, Lingappa, Jairam R., McElrath, M. Juliana, Mackelprang, Romel, McGowan, Ian, Cranston, Ross D., Cameron, Mark J., and Hladik, Florian

Published
2020
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4. High Baseline Anal Human Papillomavirus and Abnormal Anal Cytology in a Phase 3 Trial of the Quadrivalent Human Papillomavirus Vaccine in Human Immunodeficiency Virus–Infected Individuals Older Than 26 Years : ACTG 5298

Author

the ACTG 5298 Study Team, Cranston, Ross D., Cespedes, Michelle S., Paczuski, Pawel, Yang, Ming, Coombs, Robert W., Dragavon, Joan, Saah, Alfred, Godfrey, Catherine, Webster-Cyriaque, Jennifer Y., Chiao, Elizabeth Y., Bastow, Barbara, and Wilkin, Timothy

Published
2018

6. MTN-017: A Rectal Phase 2 Extended Safety and Acceptability Study of Tenofovir Reduced-Glycerin 1% Gel

Author

MTN-017 Protocol Team, Cranston, Ross D., Lama, Javier R., Richardson, Barbra A., Carballo-Diéguez, Alex, Ayudhya, Ratiya Pamela Kunjara Na, Liu, Karen, Patterson, Karen B., Leu, Cheng-Shiun, Galaska, Beth, Jacobson, Cindy E., Parikh, Urvi M., Marzinke, Mark A., Hendrix, Craig W., Johnson, Sherri, Piper, Jeanna M., Grossman, Cynthia, Ho, Ken S., Lucas, Jonathan, Pickett, Jim, Bekker, Linda-Gail, Chariyalertsak, Suwat, Chitwarakorn, Anupong, Gonzales, Pedro, Holtz, Timothy H., Liu, Albert Y., Mayer, Kenneth H., Zorrilla, Carmen, Schwartz, Jill L., Rooney, James, and McGowan, Ian

Published
2017

7. Screening strategies for the detection of anal high-grade squamous intraepithelial lesions in women living with HIV

Author

Chiao, Elizabeth Y., Lensing, Shelly Y., Wiley, Dorothy J., Deshmukh, Ashish A., Lee, Jeannette, Darragh, Teresa M., Einstein, Mark H., Jay, Naomi, Berry-Lawhorn, John Michael, Palefsky, Joel M., Wilkin, Timothy, Barroso, Luis F., Cranston, Ross D., Levine, Rebecca, Guiot, Humberto M., French, Audrey L., Citron, Deborah, Rezaei, Masoumeh Katayoon, Goldstone, Stephen E., and Stier, Elizabeth A.

Published
2020
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8. The association of medication use with clearance or persistence of oral HPV infection

Author

Lam, Jennifer O., Sugar, Elizabeth A., Cranston, Ross D., Weber, Kathleen M., Burk, Robert D., Wiley, Dorothy J., Reddy, Susheel, Margolick, Joseph B., Strickler, Howard D., Wentz, Alicia, Jacobson, Lisa, Coles, Christian L., Bream, Jay H., Rositch, Anne F., Guo, Yingshi, Xiao, Weihong, Gillison, Maura L., and D’Souza, Gypsyamber

Published
2016

9. Impact of Obefazimod on Viral Persistence, Inflammation, and Immune Activation in People With Human Immunodeficiency Virus on Suppressive Antiretroviral Therapy.

Author

Bernal, Silvia, Puertas, Maria C, Morón-López, Sara, Cranston, Ross D, Urrea, Víctor, Dalmau, Judith, Salgado, María, Gálvez, Cristina, Erkizia, Itziar, McGowan, Ian, Scherrer, Didier, Revollo, Boris, Sirera, Guillem, Santos, José Ramón, Clotet, Bonaventura, Paredes, Roger, and Martinez-Picado, Javier

Subjects
HIV, ANTIRETROVIRAL agents, HIV-positive persons
Abstract

Background Persistence of viral reservoirs has been observed in people with human immunodeficiency virus (HIV), despite long-term antiretroviral therapy (ART), and likely contributes to chronic immune activation and inflammation. Obefazimod is a novel drug that inhibits human immunodeficiency virus type 1 (HIV-1) replication and reduces inflammation. Here we assess whether obefazimod is safe and might impact HIV-1 persistence, chronic immune activation, and inflammation in ART-suppressed people with HIV. Methods We evaluated obefazimod-related adverse events, changes in cell-associated HIV-1 DNA and RNA, residual viremia, immunophenotype, and inflammation biomarkers in blood and rectal tissue. We compared 24 ART-suppressed people with HIV who received daily doses of 50 mg obefazimod for 12 weeks (n = 13) or 150 mg for 4 weeks (n = 11) and 12 HIV-negative individuals who received 50 mg for 4 weeks. Results The 50- and 150-mg doses of obefazimod were safe, although the 150-mg dose showed inferior tolerability. The 150-mg dose reduced HIV-1 DNA (P =.008, median fold change = 0.6) and residual viremia in all individuals with detectable viremia at baseline. Furthermore, obefazimod upregulated miR-124 in all participants and reduced the activation markers CD38, HLA-DR, and PD-1 and several inflammation biomarkers. Conclusions The effect of obefazimod by reducing chronic immune activation and inflammation suggests a potential role for the drug in virus remission strategies involving other compounds that can activate immune cells, such as latency-reversing agents. [ABSTRACT FROM AUTHOR]

Published
2023
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10. Long-acting rilpivirine as potential pre-exposure prophylaxis for HIV-1 prevention (the MWRI-01 study): an open-label, phase 1, compartmental, pharmacokinetic and pharmacodynamic assessment

Author

McGowan, Ian, Dezzutti, Charlene S, Siegel, Aaron, Engstrom, Jarret, Nikiforov, Alexiy, Duffill, Kathryn, Shetler, Cory, Richardson-Harman, Nicola, Abebe, Kaleab, Back, David, Else, Laura, Egan, Deidre, Khoo, Saye, Egan, James E, Stall, Ronald, Williams, Peter E, Rehman, Khaleel K, Adler, Amy, Brand, Rhonda M, Chen, Beatrice, Achilles, Sharon, and Cranston, Ross D

Published
2016
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11. The pharmacokinetics, pharmacodynamics, and mucosal responses to maraviroc-containing PrEP Regimens in Men who have Sex with Men

Author

McGowan, Ian, Wilkin, Timothy, Landovitz, Raphael J., Wu, Chunyuan, Chen, Ying, Marzinke, Mark A., Hendrix, Craig W., Richardson, Paul, Eshleman, Susan H., Andrade, Adriana, Chege, Wairimu, Anderson, Peter L., McCauley, Marybeth, Farley, Jason, Mayer, Kenneth H., Anton, Peter, Brand, Rhonda M., Cranston, Ross D., and Gulick, Roy

Published
2018
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13. Preference of Oral Tenofovir Disoproxil Fumarate/Emtricitabine Versus Rectal Tenofovir Reduced-Glycerin 1% Gel Regimens for HIV Prevention Among Cisgender Men and Transgender Women Who Engage in Receptive Anal Intercourse with Men

Author

Carballo-Diéguez, Alex, Giguere, Rebecca, Dolezal, Curtis, Leu, Cheng-Shiun, Balán, Iván C., Brown, III, William, Rael, Christine, Richardson, Barbra A., Piper, Jeanna M., Bekker, Linda-Gail, Chariyalertsak, Suwat, Chitwarakorn, Anupong, Gonzales, Pedro, Holtz, Timothy H., Liu, Albert, Mayer, Kenneth H., Zorrilla, Carmen D., Lama, Javier R., McGowan, Ian, Cranston, Ross D., and On Behalf of the MTN-017 Protocol Team

Published
2017
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14. Brief Participant-Centered Convergence Interviews Integrate Self-Reports, Product Returns, and Pharmacokinetic Results to Improve Adherence Measurement in MTN-017

Author

Balán, Iván C., Giguere, Rebecca, Brown, III, William, Carballo-Diéguez, Alex, Horn, Stephanie, Hendrix, Craig W., Marzinke, Mark A., Ayudhya, Ratiya Pamela Kunjara Na, Patterson, Karen, Piper, Jeanna M., McGowan, Ian, Lama, Javier R., Cranston, Ross D., and on behalf of the MTN-017 Protocol Team

Published
2017
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18. Brief Report: Routine Use of Oral PrEP in a Phase 2 Rectal Microbicide Study of Tenofovir Reduced-Glycerin 1% Gel (MTN-017)

Author

Liu, Albert Y., Norwood, Aliza, Gundacker, Holly, Carballo-Diéguez, Alex, Johnson, Sherri, Patterson, Karen, Bekker, Linda-Gail, Chariyalertsak, Suwat, Chitwarakorn, Anupong, Gonzales, Pedro, Holtz, Timothy H., Mayer, Kenneth H., Zorrilla, Carmen, Buchbinder, Susan, Piper, Jeanna M., Lama, Javier R., and Cranston, Ross D.

Published
2019
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30. Association of serum cytokines with oral HPV clearance☆

Author

Lam, Jennifer O., Bream, Jay H., Sugar, Elizabeth A., Coles, Christian L., Weber, Kathleen M., Burk, Robert D., Wiley, Dorothy J., Cranston, Ross D., Reddy, Susheel, Margolick, Joseph B., Strickler, Howard D., Wentz, Alicia, Jacobson, Lisa, Guo, Yingshi, Xiao, Weihong, Gillison, Maura L., and D’Souza, Gypsyamber

Published
2016
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33. Xpert HPV as a Screening Tool for Anal Histologic High-Grade Squamous Intraepithelial Lesions in Women Living With HIV.

Author

Ellsworth, Grant B., Stier, Elizabeth A., Chiao, Elizabeth Y., Lensing, Shelly Y., Darragh, Teresa, Jay, Naomi, Berry-Lawhorn, J. Michael, Einstein, Mark, Barroso, Luis F., Cranston, Ross D., Levine, Rebecca, Guiot, Humberto M., French, Audrey L., Goldstone, Stephen E., Preiser, Wolfgang, Claassen, Mathilda, Palefsky, Joel M., and Wilkin, Timothy J.

Published
2022
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34. Inaccuracy of haemoglobin A1c among HIV-infected men: effects of CD4 cell count, antiretroviral therapies and haematological parameters

Author

Slama, Laurence, Palella, Frank J., Jr, Abraham, Alison G., Li, Xiuhong, Vigouroux, Corinne, Pialoux, Gilles, Kingsley, Lawrence, Lake, Jordan E., Brown, Todd T., Margolick, Joseph B., Crain, Barbara, Dobs, Adrian, Farzadegan, Homayoon, Gallant, Joel, Johnson-Hill, Lisette, Plankey, Michael, Sacktor, Ned, Selnes, Ola, Shepard, James, Thio, Chloe, Wolinsky, Steven M., Phair, John P., Badri, Sheila, OʼGorman, Maurice, Ostrow, David, Palella, Frank, Ragin, Ann, Detels, Roger, Martínez-Maza, Otoniel, Aronow, Aaron, Bolan, Robert, Breen, Elizabeth, Butch, Anthony, Jamieson, Beth, Miller, Eric N., Oishi, John, Vinters, Harry, Wiley, Dorothy, Witt, Mallory, Yang, Otto, Young, Stephen, Zhang, Zuo Feng, Rinaldo, Charles R., Kingsley, Lawrence A., Becker, James T., Cranston, Ross D., Martinson, Jeremy J., Mellors, John W., Silvestre, Anthony J., Stall, Ronald D., Jacobson, Lisa P., Munoz, Alvaro, Abraham, Alison, Althoff, Keri, Cox, Christopher, DʼSouza, Gypsyamber, Golub, Elizabeth, Schollenberger, Janet, Seaberg, Eric C., Su, Sol, Huebner, Robin E., and Dominguez, Geraldina

Published
2014
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39. A Randomized, Double Blind, Placebo-Controlled, Phase 1 Safety, and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults (MTN-026).

Author

Cranston, Ross D., Brown, Elizabeth, Bauermeister, José, Dunne, Eileen F., Hoesley, Craig, Ho, Ken, Johnson, Sherri, Lucas, Jonathan, Dominguez-Islas, Clara, Gundacker, Holly, Peda, Melissa, Jacobson, Cindy E., Kramzer, Lindsay, Singh, Devika, Dezzutti, Charlene S., Kunjara Na Ayudhya, Ratiya Pamela, Brand, Rhonda M., Wang, Lin, Marzinke, Mark A., and Piper, Jeanna

Abstract

Dapivirine (DPV), formulated as vaginal ring, demonstrated HIV risk reduction. MTN-026 explored DPV, formulated as rectal gel, for safety, pharmacokinetics (PK), and acceptability. HIV-uninfected men and women aged 18–45 years were enrolled at United States and Thailand sites and randomized 2:1 to receive DPV 0.05% or placebo gel via rectal applicator. A single-dose phase was followed by seven observed daily doses. Plasma and fluid and tissue from both rectum and cervix were collected at baseline and after the final dose over 72 h for PK, ex-vivo HIV-1 biopsy challenge, histology, and flow cytometry. Twenty-eight participants were randomized; 2 terminated early; 9 were female and 19 male; 12 were white, 11 Asian, 4 black, and 1 other race/ethnicity. Mean age was 28.5 and 34.2 years in the DPV and placebo arms, respectively. Thirty adverse events occurred (all Grade 1 or 2, except one unrelated Grade 3) without study arm differences. DPV rectal tissue concentrations [median (interquartile range)] 0.5–1 and 2 h after a single dose were 256 ng/g [below the lower limit of quantification (BLQ)–666] and BLQ (BLQ–600), respectively, then BLQ (BLQ–BLQ) from 24 to 72 h; concentrations following multiple doses were similar. The largest median DPV plasma concentrations were 0.33 ng/mL (0.15–0.48) after one dose and 0.40 (0.33–0.49) after seven doses. The DPV rectal gel was acceptable and without safety concerns. While DPV plasma concentrations were similar to the vaginal ring, rectal tissue concentrations were well below vaginal ring tissue concentrations, suggesting need for reformulation. Clinical trial number: NCT03239483. [ABSTRACT FROM AUTHOR]

Published
2022
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40. An Open-Label Pharmacokinetic and Pharmacodynamic Assessment of Tenofovir Gel and Oral Emtricitabine/Tenofovir Disoproxil Fumarate.

Author

McGowan, Ian M., Kunjara Na Ayudhya, Ratiya Pamela, Brand, Rhonda M., Marzinke, Mark A., Hendrix, Craig W., Johnson, Sherri, Piper, Jeanna, Holtz, Timothy H., Curlin, Marcel E., Chitwarakorn, Anupong, Raengsakulrach, Boonyos, Doncel, Gustavo, Schwartz, Jill L., Rooney, James F., and Cranston, Ross D.

Abstract

The Microbicide Trials Network-017 study was undertaken to characterize the safety, acceptability, pharmacokinetic (PK), and pharmacodynamic profile of the reduced-glycerin (RG) 1% tenofovir (RG-TFV) gel compared to oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF). The study was a Phase 2, three-period, randomized sequence, open-label, expanded safety and acceptability crossover study. In each 8-week study period, HIV-1-uninfected participants were randomized to RG-TFV rectal gel daily or RG-TFV rectal gel before and after receptive anal intercourse (RAI) (or at least twice weekly in the event of no RAI), or daily oral FTC/TDF. A mucosal substudy was conducted at sites in the United States and Thailand. Samples were collected to evaluate PK and ex vivo biopsy challenge with HIV-1. A total of 195 men who have sex with men and transgender women were enrolled in the parent study and 37 in the mucosal substudy. As previously reported, both products were found to be safe and acceptable. Systemic TFV concentrations were significantly higher following oral exposure and daily rectal administration compared to RAI-associated product use (p < .001). All three routes of pre-exposure prophylaxis (PrEP) administration resulted in the inhibition of explant infection (p < .05), and there was a significant inverse correlation between explant HIV-1 p24 and tissue concentrations of TFV and FTC (p < .0001). Despite significant differences in systemic and mucosal drug concentrations, all three PrEP regimens were able to protect rectal explants from ex vivo HIV infection. These data suggest that there is a rationale for co-development of oral and topical antiretroviral PrEP for HIV prevention. Clinical Trial Registration number: NCT01687218. [ABSTRACT FROM AUTHOR]

Published
2022
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41. A Randomized, Open-Label, Crossover Phase 1 Safety and Pharmacokinetic Study of Oral Maraviroc and Maraviroc 1% Gel (the CHARM-03 Study).

Author

McGowan, Ian M., Chawki, Sylvain, Hendrix, Craig W., Anton, Peter A., Marzinke, Mark A., Brand, Rhonda M., Engstrom, Jarret C., Rohan, Lisa C., Abebe, Kaleab Z., Richardson-Harman, Nicola, Siegel, Aaron, Reinhart, Alex, Steytler, John, Stall, Ronald, Spiegel, Hans, Chen, Beatrice, Achilles, Sharon L., Jacobson, Cindy E., Khanukova, Elena, and Cranston, Ross D.

Abstract

The Combination HIV Antiretroviral Rectal Microbicide-3 (CHARM-03) study was a randomized, open-label, crossover Phase 1 safety and pharmacokinetic (PK) study of oral maraviroc (MVC) and MVC 1% gel. At a single site, healthy HIV-uninfected men and women were enrolled and randomized to an open label crossover sequence of eight consecutive daily exposures to MVC 300 mg dosed orally, MCV 1% gel dosed rectally, and MVC 1% gel dosed vaginally. Male participants received oral and rectal dosing and female participants received oral, rectal, and vaginal dosing. Assessments were undertaken at baseline and following each 8-day period and included collection of plasma, rectal/cervical tissue (CT), and rectal/endocervical/vaginal fluids. Eleven men and nine women were enrolled. Two participants withdrew from the study before receiving study product. There were 25 adverse events, of which 24 were Grade 1 (G1) and one was G2 (unrelated). After eight doses, MVC was quantifiable in all samples following oral, rectal, or vaginal product administration. The highest drug concentrations in plasma, rectal tissue (RT), and CT were associated with oral, rectal, and vaginal drug delivery, respectively. There were significant reductions in tissue drug concentrations when rectal and cervical biopsies were incubated in media before tissue processing for PK (p < .0001). Only oral MVC was associated with limited protection in the rectal explant HIV challenge model (p < .05). There were no immunological changes in RT, and all products were acceptable to participants. In conclusion, all products were found to be safe and acceptable and did not induce local inflammation. The lack of ex vivo efficacy demonstrated in study samples may be due to rapid disassociation of MVC from the explant tissue. ClinicalTrials.gov Identifier: NCT02346084. [ABSTRACT FROM AUTHOR]

Published
2022
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42. Self-collected versus clinician-collected anal cytology specimens to diagnose anal intraepithelial neoplasia in HIV-positive men

Author

Efird, Jimmy T., Palefsky, Joel M., Cranston, Ross D., Darragh, Teresa M., Holly, Elizabeh A., Jay, Naomi, Berry, J. Michael, and Da Costa, Maria

Subjects
Anal intercourse -- Research, Homosexuality, Male -- Research, Health
Abstract

A study was conducted among men who have sex with (MSM) with clinician-collected anal cytology and histopathology specimens were analyzed from a cohort study of anal intraepithelial neoplasia (AIN). The sensitivity of both self-collected and clinician-collected samples to detect AIN 2 or 3 was higher among HIV-positive MSM than among HIV-negative MSM.

Published
2004

46. Oral tenofovir disoproxil fumarate/emtricitabine for HIV pre-exposure prophylaxis increases expression of type I/III interferon-stimulated factors in the gastrointestinal tract but not in the blood

Author

Hughes, Sean M., Levy, Claire N., Calienes, Fernanda, Stekler, Joanne D., Pandey, Urvashi, Vojtech, Lucia, Berard, Alicia R., Birse, Kenzie, Noel-Romas, Laura, Richardson, Brian, Golden, Jackelyn B., Cartwright, Michael, Collier, Ann C., Stevens, Claire E., Curlin, Marcel E., Holtz, Timothy H., Mugo, Nelly, Irungu, Elizabeth, Katabira, Elly, Muwonge, Timothy, Lama, Javier R., Baeten, Jared M., Burgener, Adam, Lingappa, Jairam R., McElrath, M. Juliana, Mackelprang, Romel, McGowan, Ian, Cranston, Ross D., Cameron, Mark J., and Hladik, Florian

Subjects
virus diseases
Abstract

Tenofovir disoproxil fumarate and emtricitabine are used for HIV treatment and pre-exposure prophylaxis. Previously, we found that topical rectal application of tenofovir 1% gel caused many gene expression changes. Here, we measured RNA and protein expression in several clinical trials of oral administration in HIV-uninfected individuals (using microarrays, RNAseq, droplet digital PCR, mass spectrometry, and microscopy). We found tens to hundreds of differentially expressed genes in the gastrointestinal tract, but none in the blood or female reproductive tract. In rectal samples from one trial, most of the 13 upregulated genes were related to type I/III interferon signaling. Similar changes were seen at the protein level in the same trial and in the duodenum and rectum in another trial. We conclude that tenofovir disoproxil fumarate and emtricitabine have little effect on gene expression in the blood or female reproductive tract but increase type I/III interferon signaling in the gut. This effect may enhance their anti-viral efficacy when used as pre-exposure prophylaxis, in particular to prevent rectal HIV transmission. However, it may also contribute to chronic immune activation and HIV reservoir maintenance in chronically treated people living with HIV.

Published
2019
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48. Effective Treatment of Lymphogranuloma venereum Proctitis With Azithromycin.

Author

Blanco, José L, Fuertes, Irene, Bosch, Jordi, Lazzari, Elisa De, Gonzalez-Cordón, Ana, Vergara, Andrea, Blanco-Arevalo, Alejandro, Mayans, Josep, Inciarte, Alexy, Estrach, Teresa, Martinez, Esteban, Cranston, Ross D, Gatell, Josep M, and Alsina-Gibert, Merce

Subjects
LYMPHOGRANULOMA venereum, CEFTRIAXONE, REVERSE transcriptase polymerase chain reaction, CLINICAL trials, RECTAL diseases, ORAL drug administration, DOXYCYCLINE, TREATMENT effectiveness, AZITHROMYCIN, MEN who have sex with men, STATISTICAL sampling, POLYMERASE chain reaction, HIV
Abstract

Background Lymphogranuloma venereum (LGV) is a sexually transmitted infection caused by Chlamydia trachomatis (CT) serovars L1, L2, and L3 and is endemic among men who have sex with men (MSM) in Europe. We evaluated weekly oral azithromycin 1 g for 3 weeks as a treatment for LGV proctitis. Methods This is an open clinical trial with convenience allocation according to treating physician preferences. Adults with clinical proctitis received a single dose of 1 g of intramuscular ceftriaxone and were subsequently allocated to receive (i) doxycycline 100 mg twice daily for 21 days (Doxycycline group) or (ii) azithromycin 1 g orally once weekly for 3 weeks (Azithromycin group). LGV cure (primary endpoint) was defined as resolution of symptoms at week 6 (clinical cure, LGV-CC), with an additional supporting negative rectal polymerase chain reaction (PCR) at week 4 (microbiological cure, LGV-MC), if available. Results One hundred and twenty-five individuals with LGV clinical proctitis were included. All were MSM, and 96% were living with human immunodeficiency virus (HIV). Eighty-two were in the Azithromycin group, and 43 were in the Doxycycline group. LGV cure on a modified intention-to-treat analysis (primary endpoint), occurred in 80 of 82 (98%) in the Azithromycin group versus 41 of 43 (95%) in the Doxycycline group (treatment difference [95% confidence interval {CI}] 2.2% [−3.2, 13.2]). LGV-MC occurred in 70 of 72 (97%) vs 15 of 15 (100%) in the Azithromycin group and Doxycycline group, respectively (treatment difference [95% CI] −2.8% [−9.6; 17.7]). Adverse events were similar in both treatment groups. Conclusions Our findings support extended azithromycin dosing as an alternative treatment option for symptomatic LGV proctitis and provides the rationale for future randomized trials. [ABSTRACT FROM AUTHOR]

Published
2021
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49. Higher colorectal tissue HIV infectivity in cisgender women compared with MSM before and during oral preexposure prophylaxis.

Author

Sekabira, Rogers, McGowan, Ian, Yuhas, Krista, Bran, Rhonda M., Marzinke, Mark A., Manabe, Yukari C., Frank, Ian, Eron, Joseph, Landovitz, Raphael J., Anton, Peter, Cranston, Ross D., Anderson, Peter, Mayer, Kenneth H., Rivet Amico, K., Wilkin, Timothy J., Chege, Wairimu, Kekitiinwa, Adeodata R., McCauley, Marybeth, Gulick, Roy M., and Hendrix, Craig W.

Published
2021
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50. Xpert HPV as a Screening Tool for Anal Histologic High-Grade Squamous Intraepithelial Lesions in Women Living With HIV.

Author

Ellsworth, Grant B., Stier, Elizabeth A., Chiao, Elizabeth Y., Lensing, Shelly Y., Darragh, Teresa, Jay, Naomi, Berry-Lawhorn, J. Michael, Einstein, Mark, Barroso, Luis F., Cranston, Ross D., Levine, Rebecca, Guiot, Humberto M., French, Audrey L., Goldstone, Stephen E., Preiser, Wolfgang, Claassen, Mathilda, Palefsky, Joel M., and Wilkin, Timothy J.

Published
2021
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