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5 results on '"Makanani, Bonus"'

1. Additional file 3 of Maternal and infant renal safety following tenofovir disoproxil fumarate exposure during pregnancy in a randomized control trial

Author

Baltrusaitis, Kristin, Makanani, Bonus, Tierney, Camlin, Fowler, Mary Glenn, Moodley, Dhayendre, Theron, Gerhard, Nyakudya, Lynette H., Tomu, Musunga, Fairlie, Lee, George, Kathleen, Heckman, Barbara, Knowles, Kevin, Browning, Renee, Siberry, George K., Taha, Taha E., and Stranix-Chibanda, Lynda

Abstract

Additional file 3: Additional Baseline Characteristics.

Published
2022
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2. Additional file 1 of Maternal and infant renal safety following tenofovir disoproxil fumarate exposure during pregnancy in a randomized control trial

Author

Baltrusaitis, Kristin, Makanani, Bonus, Tierney, Camlin, Fowler, Mary Glenn, Moodley, Dhayendre, Theron, Gerhard, Nyakudya, Lynette H., Tomu, Musunga, Fairlie, Lee, George, Kathleen, Heckman, Barbara, Knowles, Kevin, Browning, Renee, Siberry, George K., Taha, Taha E., and Stranix-Chibanda, Lynda

Abstract

Additional file 1: PROMISE Study Design.

Published
2022
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3. Additional file 4 of Maternal and infant renal safety following tenofovir disoproxil fumarate exposure during pregnancy in a randomized control trial

Author

Baltrusaitis, Kristin, Makanani, Bonus, Tierney, Camlin, Fowler, Mary Glenn, Moodley, Dhayendre, Theron, Gerhard, Nyakudya, Lynette H., Tomu, Musunga, Fairlie, Lee, George, Kathleen, Heckman, Barbara, Knowles, Kevin, Browning, Renee, Siberry, George K., Taha, Taha E., and Stranix-Chibanda, Lynda

Abstract

Additional file 4: Table S1. PROMISE Study Follow-up Time and Tenofovir Disoproxil Fumarate (TDF) Exposure for Women Eligible for TDF Randomization.

Published
2022
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4. Additional file 2 of Maternal and infant renal safety following tenofovir disoproxil fumarate exposure during pregnancy in a randomized control trial

Author

Baltrusaitis, Kristin, Makanani, Bonus, Tierney, Camlin, Fowler, Mary Glenn, Moodley, Dhayendre, Theron, Gerhard, Nyakudya, Lynette H., Tomu, Musunga, Fairlie, Lee, George, Kathleen, Heckman, Barbara, Knowles, Kevin, Browning, Renee, Siberry, George K., Taha, Taha E., and Stranix-Chibanda, Lynda

Abstract

Additional file 2: Comparison of the ZDV ART and the ZDV Alone arms.

Published
2022
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5. Long-term follow-up of HIV seroconverters in microbicide trials - rationale, study design, and challenges in MTN-015

Author

Riddler, Sharon A, Husnik, Marla, Gorbach, Pamina M, Levy, Lisa, Parikh, Urvi, Livant, Edward, Pather, Arendevi, Makanani, Bonus, Muhlanga, Felix, Kasaro, Margaret, Martinson, Francis, Elharrar, Vanessa, Balkus, Jennifer E, and MTN-015 Protocol Team for the Microbicide Trials Network

Subjects
Male, Anti-HIV Agents, Clinical Trials and Supportive Activities, Clinical Sciences, Antiretroviral Therapy, HIV Infections, Clinical Protocols, prevention, Pregnancy, Clinical Research, Virology, Behavioral and Social Science, Topical Microbicides, Humans, Highly Active, Longitudinal Studies, seroconversion, pre-exposure prophylaxis, drug resistance, Pregnancy Outcome, HIV, cohort Study, Viral Load, clinical trial design, CD4 Lymphocyte Count, Treatment Outcome, Infectious Diseases, Good Health and Well Being, microbicides, Research Design, HIV-1, HIV/AIDS, Female, MTN-015 Protocol Team for the Microbicide Trials Network, Infection
Abstract

BackgroundAs the effect of biomedical prevention interventions on the natural history of HIV-1 infection in participants who seroconvert is unknown, the Microbicide Trials Network (MTN) established a longitudinal study (MTN-015) to monitor virologic, immunological, and clinical outcomes, as well as behavioral changes among women who become HIV-infected during MTN trials. We describe the rationale, study design, implementation, and enrollment of the initial group of participants in the MTN seroconverter cohort.MethodsInitiated in 2008, MTN-015 is an ongoing observational cohort study enrolling participants who acquire HIV-1 infection during effectiveness studies of candidate microbicides. Eligible participants from recently completed and ongoing MTN trials are enrolled after seroconversion and return for regular follow-up visits with clinical and behavioral data collection. Biologic samples including blood and genital fluids are stored for future testing.ResultsMTN-015 was implemented initially at six African sites and enrolled 100/139 (72%) of eligible women who seroconverted in HIV Prevention Trials Network protocol 035 (HPTN 035, conducted by the MTN). The median time from seroconversion in HPTN 035 to enrollment in MTN-015 was 18months. Retention was good with >70% of visits completed. Implementation challenges included regulatory reviews, translation, and testing of questionnaires, and site readiness.ConclusionsEnrollment of HIV-seroconverters into a longitudinal observational follow-up study is feasible and acceptable to participants. Data and samples collected in this protocol will be used to assess safety of investigational HIV microbicides and answer other important public health questions for HIV infected women.

Published
2016

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