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3 results on '"Ramirez-Cardich, ME"'

1. Effects of Emtricitabine/Tenofovir on Bone Mineral Density in HIV-Negative Persons in a Randomized, Double-Blind, Placebo-Controlled Trial

Author

Mulligan, K, Glidden, DV, Anderson, PL, Liu, A, McMahan, V, Gonzales, P, Ramirez-Cardich, ME, Namwongprom, S, Chodacki, P, De Mendonca, LMC, Wang, F, Lama, JR, Chariyalertsak, S, Guanira, JV, Buchbinder, S, Bekker, LG, Schechter, M, Veloso, VG, Grant, RM, Vargas, L, Sanchez, J, Mai, C, Saokhieo, P, Murphy, K, Gilmore, H, Holland, S, Faber, E, Duda, J, Bewerunge, L, Batist, E, Hoskin, C, Brown, B, De Janeiro, R, Beppu-Yoshida, C, Da Costa, MD, Assis De Jesus, SC, Grangeiro Da Silva, JR, Millan, R, De Siqueira Hoagland, BR, Martinez Fernandes, N, Da Silva Freitas, L, Grinsztejn, B, Pilotto, J, Bushman, L, Zheng, JH, Anthony Guida, L, Kline, B, Goicochea, P, Manzo, J, Hance, R, McConnell, J, Defechereux, P, Levy, V, Robles, M, Postle, B, Burns, D, and Rooney, J

Subjects
Adult, Male, musculoskeletal diseases, Microbiology (medical), Cytoplasm, medicine.medical_specialty, Adolescent, Bone density, Anti-HIV Agents, Urology, Placebo-controlled study, Administration, Oral, HIV Infections, Emtricitabine, Placebo, Chemoprevention, Placebos, Plasma, Young Adult, Pre-exposure prophylaxis, Absorptiometry, Photon, Double-Blind Method, immune system diseases, Bone Density, Internal medicine, Humans, Medicine, Tenofovir, Articles and Commentaries, business.industry, virus diseases, Middle Aged, Emtricitabine/Tenofovir, Confidence interval, Discontinuation, Infectious Diseases, Endocrinology, Female, business, medicine.drug
Abstract

Author(s): Mulligan, Kathleen; Glidden, David V; Anderson, Peter L; Liu, Albert; McMahan, Vanessa; Gonzales, Pedro; Ramirez-Cardich, Maria Esther; Namwongprom, Sirianong; Chodacki, Piotr; de Mendonca, Laura Maria Carvalo; Wang, Furong; Lama, Javier R; Chariyalertsak, Suwat; Guanira, Juan Vicente; Buchbinder, Susan; Bekker, Linda-Gail; Schechter, Mauro; Veloso, Valdilea G; Grant, Robert M; Preexposure Prophylaxis Initiative Study Team | Abstract: BackgroundDaily preexposure prophylaxis (PrEP) with oral emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) decreases the risk of human immunodeficiency virus (HIV) acquisition. Initiation of TDF decreases bone mineral density (BMD) in HIV-infected people. We report the effect of FTC/TDF on BMD in HIV-seronegative men who have sex with men and in transgender women.MethodsDual-energy X-ray absorptiometry was performed at baseline and 24-week intervals in a substudy of iPrEx, a randomized, double-blind, placebo-controlled trial of FTC/TDF PrEP. Plasma and intracellular tenofovir concentrations were measured in participants randomized to FTC/TDF.ResultsIn 498 participants (247 FTC/TDF, 251 placebo), BMD in those randomized to FTC/TDF decreased modestly but statistically significantly by 24 weeks in the spine (net difference, -0.91% [95% confidence interval {CI}, -1.44% to -.38%]; P = .001) and hip (-0.61% [95% CI, -.96% to -.27%], P = .001). Changes within each subsequent 24-week interval were not statistically significant. Changes in BMD by week 24 correlated inversely with intracellular tenofovir diphosphate (TFV-DP), which was detected in 53% of those randomized to FTC/TDF. Net BMD loss by week 24 in participants with TFV-DP levels indicative of consistent dosing averaged -1.42% ± 29% and -0.85% ± 19% in the spine and hip, respectively (P l .001 vs placebo). Spine BMD tended to rebound following discontinuation of FTC/TDF. There were no differences in fractures (P = .62) or incidence of low BMD.ConclusionsIn HIV-uninfected persons, FTC/TDF PrEP was associated with small but statistically significant decreases in BMD by week 24 that inversely correlated with TFV-DP, with more stable BMD thereafter.Clinical trials registrationNCT00458393.

Published
2015

2. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men.

Author

Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapía M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernández T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallás EG, Amico KR, Mulligan K, Bushman LR, Hance RJ, Ganoza C, Defechereux P, Postle B, Wang F, McConnell JJ, Zheng JH, Lee J, Rooney JF, Jaffe HS, Martinez AI, Burns DN, and Glidden DV

Subjects
Adenine adverse effects, Adenine blood, Adenine therapeutic use, Administration, Oral, Adolescent, Adult, Anti-HIV Agents adverse effects, Anti-HIV Agents blood, Deoxycytidine adverse effects, Deoxycytidine blood, Deoxycytidine therapeutic use, Drug Resistance, Viral, Drug Therapy, Combination, Emtricitabine, Follow-Up Studies, HIV genetics, HIV isolation & purification, HIV Antibodies blood, HIV Infections diagnosis, HIV Infections epidemiology, HIV Seropositivity diagnosis, Humans, Incidence, Kaplan-Meier Estimate, Male, Middle Aged, Nausea chemically induced, Organophosphonates adverse effects, Organophosphonates blood, Patient Compliance, RNA, Viral blood, Tenofovir, Transsexualism, Young Adult, Adenine analogs & derivatives, Anti-HIV Agents therapeutic use, Deoxycytidine analogs & derivatives, HIV Infections prevention & control, Homosexuality, Male, Organophosphonates therapeutic use
Abstract

Background: Antiretroviral chemoprophylaxis before exposure is a promising approach for the prevention of human immunodeficiency virus (HIV) acquisition., Methods: We randomly assigned 2499 HIV-seronegative men or transgender women who have sex with men to receive a combination of two oral antiretroviral drugs, emtricitabine and tenofovir disoproxil fumarate (FTC-TDF), or placebo once daily. All subjects received HIV testing, risk-reduction counseling, condoms, and management of sexually transmitted infections., Results: The study subjects were followed for 3324 person-years (median, 1.2 years; maximum, 2.8 years). Of these subjects, 10 were found to have been infected with HIV at enrollment, and 100 became infected during follow-up (36 in the FTC-TDF group and 64 in the placebo group), indicating a 44% reduction in the incidence of HIV (95% confidence interval, 15 to 63; P=0.005). In the FTC-TDF group, the study drug was detected in 22 of 43 of seronegative subjects (51%) and in 3 of 34 HIV-infected subjects (9%) (P<0.001). Nausea was reported more frequently during the first 4 weeks in the FTC-TDF group than in the placebo group (P<0.001). The two groups had similar rates of serious adverse events (P=0.57)., Conclusions: Oral FTC-TDF provided protection against the acquisition of HIV infection among the subjects. Detectable blood levels strongly correlated with the prophylactic effect. (Funded by the National Institutes of Health and the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT00458393.).

Published
2010
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3. Effect of maternal anemia at high altitude on infant hematocrit and oxygenation.

Author

Ramirez-Cardich ME, Saito M, Gilman RH, Escate LE, Strouse JJ, Kabrhel C, Johnson C, Galchen R, and Bautista CT

Subjects
Adult, Female, Hematocrit, Humans, Male, Oximetry, Peru, Pregnancy, Respiration, Altitude, Anemia blood, Fetal Blood, Infant, Newborn blood, Oxygen blood, Pregnancy Complications, Hematologic blood
Abstract

Hematocrit levels were determined in 36 mothers living at high altitudes (3,750 meters) and their infant cord bloods to determine the effect of maternal anemia on the infant. The arterial oxygen saturation (SaO(2)) and respiratory rate of the infants were also followed during the first four months of life. There was a negative correlation between maternal hematocrit and infant hematocrit (r(s) = - 0.57). Nineteen babies born to anemic women (hematocrit < 41%) had a significantly higher mean hematocrit (59.9%) than those born to non-anemic mothers (55.8%; P = 0.003). The SaO(2) levels and respiratory rates of infants were not different between infants born to non-anemic and anemic mothers. At high altitudes, infants from mothers with anemia have higher hematocrits than those born to non-anemic mothers.

Published
2004

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