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| ID | Type | Description | Link |
|---|---|---|---|
| 5UM1AI068633 | U.S. NIH Grant/Contract | View source | |
| 11857 | Other Identifier | DAIDS protocol # |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| National Institute of Mental Health (NIMH) | NIH |
| National Institutes of Health (NIH) | NIH |
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MTN-017 is a Phase 2, multi-site, randomized, six-sequence, two three-period, open label crossover study, examining the effects of oral Truvada and reduced glycerin 1% tenofovir gel. The study population will be sexually active, HIV-uninfected males who are 18 years of age or older, who report a history of receptive anal intercourse in the past 3 months. Each of the study product regimens offers different advantages to participants seeking an effective HIV prevention agent. How these relative advantages will compare in terms of safety, acceptability, systemic and local absorption, and adherence will be examined within this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks) |
|
| Group 2 | Active Comparator | Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks) |
|
| Group 3 | Active Comparator | Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Grade 2 or Higher Adverse Events | Compare the safety profiles of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Analysis of the primary endpoint of grade 2 or higher AEs was performed on only the evaluable participants based on the principle of intent-to-treat (ITT) whereby participants who were randomized were included in the analysis regardless of whether or not they received product in a given period (i.e, were lost to follow-up, or terminated early and/or were on a product hold). | 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
| Acceptability: Participant Self-report of Liking the Product. H1-Overall How do You Feel About the Product You Used Recently? | To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of liking the product, a variable was created by combining from Section H. Liking the Product of the MTN-017 Follow-up Behavioral Questionnaire question 1A and question 1BC. Categories 1 and 2 were combined and categories 3 and 4 were combined to create a dichotomous variable. | 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
| Acceptability: Participant Self-report of Ease of Use. I1-Overall How Easy or Difficult Was it to Use the Product? | To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of ease of use, a variable was created to compare regimens. This variable combines questions 1A and 1BC from Section I. Ease of Use of the MTN-017 Follow-up Behavioral Questionnaire. Categories 1 and 2 were combined and categories 3 and 4 were combined to create dichotomous variables. | 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
| Acceptability: Participant Self-report of Likelihood of Product Use if Shown to be Effective. N1-If This Product Provides Some Protection How Likely Would You be to Take it? |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Tenofovir (TFV) Concentrations (log10 ng/mL) in Blood Plasma | Compare tenofovir concentrations in blood plasma among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. | 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
| Pharmacokinetics: End Period Tenofovir (TFV) Concentrations (log10 ng/mg) in Rectal Tissue |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics | To characterize pharmacodynamic responses following oral and rectal exposure to antiretroviral drugs | 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
| Mucosal Immunity |
Inclusion Criteria:
Male or transgender female > age of 18 at Screening
Able and willing to provide written informed consent
HIV-1 uninfected at Screening and Enrollment
Able and willing to provide adequate locator information, as defined in site SOP
Available to return for all study visits, barring unforeseen circumstances and willing to comply with study participation requirements
In general good health at Screening and Enrollment, as determined by the site IoR or designee
Per participant report, a history of consensual RAI at least once in the past 3 months
Per participant report at Screening and Enrollment, agrees not to engage in receptive or insertive sexual activity with another study participant for the duration of study participation.
Willing to use study-provided condoms for the duration of the study for penetrative intercourse
Willing to not take part in other research studies involving drugs, medical devices, vaccines or genital products for the duration of study participation (including the time between Screening and Enrollment)
Men and transgender females who agree to take part in the PK, PD and Mucosal Immunology Subset, must also agree to abstain from:
Exclusion Criteria:
At Screening, participant-reported symptoms, and/or clinical or laboratory diagnosis of active anorectal or reproductive tract infection requiring treatment per current World Health Organization (WHO) guidelines or symptomatic urinary tract infection (UTI). Infections requiring treatment include symptomatic Chlamydia trachomatis (CT) infection, Neisseria gonorrhea (GC), syphilis, active herpes simplex virus (HSV) lesions, anogenital sores or ulcers, or symptomatic genital warts.
Note: HSV-1 or HSV-2 seropositive diagnosis with no active lesions is allowed, since treatment is not required.
In cases of non-anorectal GC/CT identified at screening, one re-screening 2 months after the screening visit will be allowed
History of inflammatory bowel disease as reported by participant history
At Screening:
Known allergy to methylparaben and/or propylparaben
Known allergy to any of the study products.
Per participant report, use of the following medications and/or products within 12 weeks prior to screening, and/or anticipated use or unwillingness to abstain from use throughout study participation:
By participant report, use of post-exposure prophylaxis (PEP) for HIV exposure within the 12 weeks prior to screening or anticipated use during study participation.
Symptoms suggestive of acute HIV seroconversion at Screening and Enrollment
Has any other condition that, in the opinion of the Investigator of Record (IoR)/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives would make the patient unsuitable for the study or unable/unwilling to comply with the study requirements. Such conditions may include, but are not limited to, colorectal abnormalities, substance abuse, or renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological or psychiatric disease.
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| Name | Affiliation | Role |
|---|---|---|
| Ross D. Cranston, MD, FRCP | University of Pittsburgh Medical Center (UPMC) | Study Chair |
| Javier R. Lama, MD, MPH | Asociacion Civil Impacta Salud y Educacion (IMPACTA) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HIV Research Section, San Francisco - Department of Public Health | San Francisco | California | 94102 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27986684 | Result | Cranston RD, Lama JR, Richardson BA, Carballo-Dieguez A, Kunjara Na Ayudhya RP, Liu K, Patterson KB, Leu CS, Galaska B, Jacobson CE, Parikh UM, Marzinke MA, Hendrix CW, Johnson S, Piper JM, Grossman C, Ho KS, Lucas J, Pickett J, Bekker LG, Chariyalertsak S, Chitwarakorn A, Gonzales P, Holtz TH, Liu AY, Mayer KH, Zorrilla C, Schwartz JL, Rooney J, McGowan I; MTN-017 Protocol Team. MTN-017: A Rectal Phase 2 Extended Safety and Acceptability Study of Tenofovir Reduced-Glycerin 1% Gel. Clin Infect Dis. 2017 Mar 1;64(5):614-620. doi: 10.1093/cid/ciw832. | |
| 28750059 |
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349 persons were screened and 154 were excluded for various reasons. The study enrolled 195 participants, 187 of whom are evaluable. Evaluable participants are those participants who were enrolled and not replaced, or were the final enrolled replacement participant for another enrolled participant who met the criteria for replacement.
HIV-uninfected males or transgender females who were 18 years of age or older who practice receptive anal intercourse were recruited from September 2013 through November 2014 from 8 sites in Peru, Puerto Rico, South Africa, Thailand and USA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks) Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet) Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel) Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Group 4 | Active Comparator | Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks) |
|
| Group 5 | Active Comparator | Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks) |
|
| Group 6 | Active Comparator | Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks);followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks) |
|
| Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel) | Drug |
|
| Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel) | Drug |
|
To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of likelihood to use product in the future, a variable was created by combining Section N. Likelihood to Use Product in the Future of the MTN-017 Follow-up Behavioral Questionnaire questions 1A, 1B, and 1C. Categories 1 and 2 were combined and categories 3 and 4 were combined to create a dichotomous variable. |
| 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
Compare end period tenofovir concentrations in rectal tissue among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. |
| 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
| Pharmacokinetics: Tenofovir (TFV) Concentrations (log10 ng/mg) in Rectal Sponge | Compare tenofovir concentrations in rectal sponge specimens among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. | 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
| Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mL) in Blood Plasma | Compare emtricitabine concentrations in blood plasma among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. | 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
| Pharmacokinetics: End Period Emtricitabine (FTC) Concentrations (log10 ng/mg) in Rectal Tissue | Compare end period emtricitabine concentrations in rectal tissue among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. | 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
| Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mg) in Rectal Sponge | Compare emtricitabine concentrations in rectal sponge among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. | 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
| Pharmacokinetics: End Period Tenofovir-Diphosphate (TFV-DP) Concentrations (log10 ng/mg) in Rectal Tissue | Compare end period tenofovir-diphosphate (TFV-DP) concentrations in rectal tissue among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. | 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
| Adherence: Percentage of Prescribed Doses Taken Orally or Administered Rectally in an 8-week Period | Compare percentage of prescribed doses taken orally or administered rectally in an 8-week period based on the Final Converged Rates. Final Converged Rates were measured first via self-report through Short Message Service (SMS). The clinic staff also reported the most likely number of doses taken. Finally, the MTN Behavioral Research Working Group (BRWG) provided the final estimate of the number of doses taken for each participant for each period based on self-report, staff estimates and PK testing results. Note that these final judgement data are missing if PK results are missing. | 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
To characterize changes in mucosal immunity between baseline and the end of the daily FTC/TDF and TFV RG 1% gel product use
| 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
| Correlation Between PK and Adherence | To assess correlation of PK with adherence measures | 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
| Factors Associated With Adherence | To identify factors associated with product adherence and whether they differ by product used (FTC/TDF or TFV RG 1% gel) or regimen (daily use or RAI-associated use) | 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
| Sexual Activity and Condom Use | To examine whether sexual activity or condom use varies by product used | 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
| Product Sharing | To determine the level of sharing of study products with non-participants and to assess with whom products are shared | 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
| Problem Practices | To determine the prevalence of behavioral practices associated with anal intercourse that may affect microbicide use | 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
| The Fenway Institute/Fenway Community Health |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| University of Pittsburgh Medical Center (UPMC) | Pittsburgh | Pennsylvania | 15213 | United States |
| Asociacion Civil Impacta Salud y Educacion (IMPACTA) | Lima | Peru |
| University of Puerto Rico Medical Sciences Campus - Maternal Infant Studies Center (CEMI) | San Juan | 00936-5067 | Puerto Rico |
| Desmond Tutu HIV Foundation | Cape Town | South Africa |
| Research Institute for Health Sciences - Chiang Mai University | Chiang Mai | 50202 | Thailand |
| Thailand MOPH - US CDC Collaboration (TUC) | Nonthaburi | 11000 | Thailand |
| Result |
| Carballo-Dieguez A, Balan IC, Brown W 3rd, Giguere R, Dolezal C, Leu CS, Marzinke MA, Hendrix CW, Piper JM, Richardson BA, Grossman C, Johnson S, Gomez K, Horn S, Kunjara Na Ayudhya RP, Patterson K, Jacobson C, Bekker LG, Chariyalertsak S, Chitwarakorn A, Gonzales P, Holtz TH, Liu A, Mayer KH, Zorrilla C, Lama J, McGowan I, Cranston RD. High levels of adherence to a rectal microbicide gel and to oral Pre-Exposure Prophylaxis (PrEP) achieved in MTN-017 among men who have sex with men (MSM) and transgender women. PLoS One. 2017 Jul 27;12(7):e0181607. doi: 10.1371/journal.pone.0181607. eCollection 2017. |
| 29025127 | Result | Giguere R, Brown W III, Balan IC, Dolezal C, Ho T, Sheinfil A, Ibitoye M, Lama JR, McGowan I, Cranston RD, Carballo-Dieguez A. Are participants concerned about privacy and security when using short message service to report product adherence in a rectal microbicide trial? J Am Med Inform Assoc. 2018 Apr 1;25(4):393-400. doi: 10.1093/jamia/ocx081. |
| 29119473 | Result | Carballo-Dieguez A, Giguere R, Dolezal C, Leu CS, Balan IC, Brown W 3rd, Rael C, Richardson BA, Piper JM, Bekker LG, Chariyalertsak S, Chitwarakorn A, Gonzales P, Holtz TH, Liu A, Mayer KH, Zorrilla CD, Lama JR, McGowan I, Cranston RD; MTN-017 Protocol Team. 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. AIDS Behav. 2017 Dec;21(12):3336-3345. doi: 10.1007/s10461-017-1969-1. |
| 28825142 | Result | Giguere R, Rael CT, Sheinfil A, Balan IC, Brown W 3rd, Ho T, Dolezal C, Leu CS, Liu A, Mayer KH, Lama JR, McGowan I, Carballo-Dieguez A, Cranston RD; MTN-017 Protocol Team. Factors Supporting and Hindering Adherence to Rectal Microbicide Gel Use with Receptive Anal Intercourse in a Phase 2 Trial. AIDS Behav. 2018 Feb;22(2):388-401. doi: 10.1007/s10461-017-1890-7. |
| 29501908 | Result | Brown W 3rd, Giguere R, Sheinfil A, Ibitoye M, Balan I, Ho T, Brown B, Quispe L, Sukwicha W, Lama JR, Carballo-Dieguez A, Cranston RD. Challenges and solutions implementing an SMS text message-based survey CASI and adherence reminders in an international biomedical HIV PrEP study (MTN 017). J Biomed Inform. 2018 Apr;80:78-86. doi: 10.1016/j.jbi.2018.02.018. Epub 2018 Mar 6. |
| 30336747 | Result | Cranston RD, Carballo-Dieguez A, Gundacker H, Richardson BA, Giguere R, Dolezal C, Siegel A, KunjaraNaAyudhya RP, Gomez K, Piper JM, Lama JR, McGowan I; MTN-017 Protocol Team. Prevalence and determinants of anal human papillomavirus infection in men who have sex with men and transgender women. Int J STD AIDS. 2019 Feb;30(2):154-162. doi: 10.1177/0956462418797864. Epub 2018 Oct 18. |
| 30318905 | Result | Leu CS, Giguere R, Bauermeister JA, Dolezal C, Brown W 3rd, Balan IC, Richardson BA, Piper JM, Lama JR, Cranston RD, Carballo-Dieguez A. Trajectory of use over time of an oral tablet and a rectal gel for HIV prevention among transgender women and men who have sex with men. AIDS Care. 2019 Mar;31(3):379-387. doi: 10.1080/09540121.2018.1533223. Epub 2018 Oct 14. |
| 31299013 | Result | Liu AY, Norwood A, Gundacker H, Carballo-Dieguez A, Johnson S, Patterson K, Bekker LG, Chariyalertsak S, Chitwarakorn A, Gonzales P, Holtz TH, Mayer KH, Zorrilla C, Buchbinder S, Piper JM, Lama JR, Cranston RD. Brief Report: Routine Use of Oral PrEP in a Phase 2 Rectal Microbicide Study of Tenofovir Reduced-Glycerin 1% Gel (MTN-017). J Acquir Immune Defic Syndr. 2019 Aug 15;81(5):516-520. doi: 10.1097/QAI.0000000000002066. |
| 29076032 | Result | Balan IC, Giguere R, Brown W 3rd, Carballo-Dieguez A, Horn S, Hendrix CW, Marzinke MA, Ayudhya RPKN, Patterson K, Piper JM, McGowan I, Lama JR, Cranston RD; MTN-017 Protocol Team. Brief Participant-Centered Convergence Interviews Integrate Self-Reports, Product Returns, and Pharmacokinetic Results to Improve Adherence Measurement in MTN-017. AIDS Behav. 2018 Mar;22(3):986-995. doi: 10.1007/s10461-017-1955-7. |
| 41869811 | Derived | Hughes SM, Calienes FL, Levy CN, Pandey U, Gornalusse GG, Cranston RD, Lama JR, Pickett J, Brand RM, Hendrix CW, Marzinke MA, Dai JY, Balar B, Justman JE, Nair G, Berard AR, Birse K, Noel-Romas L, Mayer KH, Stekler JD, Mackelprang R, Burgener AD, McGowan I, Cameron CM, Cameron MJ, Woodrow KA, Hladik F. Mucosal tenofovir 1% gel stimulates cell proliferation and type I/III interferon pathways. Microbiol Spectr. 2026 Mar 23;14(5):e0168025. doi: 10.1128/spectrum.01680-25. Online ahead of print. |
| 34541872 | Derived | McGowan IM, Kunjara Na Ayudhya RP, Brand RM, Marzinke MA, Hendrix CW, Johnson S, Piper J, Holtz TH, Curlin ME, Chitwarakorn A, Raengsakulrach B, Doncel G, Schwartz JL, Rooney JF, Cranston RD. An Open-Label Pharmacokinetic and Pharmacodynamic Assessment of Tenofovir Gel and Oral Emtricitabine/Tenofovir Disoproxil Fumarate. AIDS Res Hum Retroviruses. 2022 Apr;38(4):279-287. doi: 10.1089/AID.2021.0115. Epub 2021 Oct 29. |
| FG001 | Group 2 | Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks) Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet) Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel) Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel) |
| FG002 | Group 3 | Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks) Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet) Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel) Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel) |
| FG003 | Group 4 | Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks) Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet) Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel) Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel) |
| FG004 | Group 5 | Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks) Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet) Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel) Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel) |
| FG005 | Group 6 | Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks);followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks) Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet) Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel) Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Includes all participants enrolled.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks) Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet) Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel) Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel) |
| BG001 | Group 2 | Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks) Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet) Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel) Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel) |
| BG002 | Group 3 | Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks) Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet) Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel) Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel) |
| BG003 | Group 4 | Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks) Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet) Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel) Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel) |
| BG004 | Group 5 | Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks) Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet) Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel) Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel) |
| BG005 | Group 6 | Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks);followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks) Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet) Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel) Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel) |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Sex/Gender, Customized | One participant from Peru did not complete a baseline CASI. | Number | participants |
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| Hispanic Origin | Number | participants |
| ||||||||||||||||
| Highest Level of Education | Number | participants |
| ||||||||||||||||
| Sexual Orientation (CASI) | One participant from Peru did not complete a baseline CASI. | Number | participants |
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| Nationality | Country in which the site clinic resides. | Number | participants |
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| Race - Puerto Rico | Number | participants |
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| Race - Peru | Number | participants |
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| Race - South Africa | Number | participants |
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| Race - Thailand | Number | participants |
| ||||||||||||||||
| Race - U.S.A. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety: Grade 2 or Higher Adverse Events | Compare the safety profiles of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Analysis of the primary endpoint of grade 2 or higher AEs was performed on only the evaluable participants based on the principle of intent-to-treat (ITT) whereby participants who were randomized were included in the analysis regardless of whether or not they received product in a given period (i.e, were lost to follow-up, or terminated early and/or were on a product hold). | Among the 187 evaluable participants. One participant was terminated before the Initiate Period visit of his/her Period 3 (Oral Tablet regimen period). Thus, this participant is removed from the analysis of the oral period regimen. | Posted | Number | participants | 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
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| Primary | Acceptability: Participant Self-report of Liking the Product. H1-Overall How do You Feel About the Product You Used Recently? | To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of liking the product, a variable was created by combining from Section H. Liking the Product of the MTN-017 Follow-up Behavioral Questionnaire question 1A and question 1BC. Categories 1 and 2 were combined and categories 3 and 4 were combined to create a dichotomous variable. | All primary analyses are based on the data from evaluable participants. Evaluable participants are those participants who were enrolled and not replaced, or were the final enrolled replacement participant for another enrolled participant who met the criteria for replacement. | Posted | Number | participants | 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Acceptability: Participant Self-report of Ease of Use. I1-Overall How Easy or Difficult Was it to Use the Product? | To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of ease of use, a variable was created to compare regimens. This variable combines questions 1A and 1BC from Section I. Ease of Use of the MTN-017 Follow-up Behavioral Questionnaire. Categories 1 and 2 were combined and categories 3 and 4 were combined to create dichotomous variables. | All primary analyses are based on the data from evaluable participants. Evaluable participants are those participants who were enrolled and not replaced, or were the final enrolled replacement participant for another enrolled participant who met the criteria for replacement. | Posted | Number | participants | 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
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| Primary | Acceptability: Participant Self-report of Likelihood of Product Use if Shown to be Effective. N1-If This Product Provides Some Protection How Likely Would You be to Take it? | To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of likelihood to use product in the future, a variable was created by combining Section N. Likelihood to Use Product in the Future of the MTN-017 Follow-up Behavioral Questionnaire questions 1A, 1B, and 1C. Categories 1 and 2 were combined and categories 3 and 4 were combined to create a dichotomous variable. | All primary analyses are based on the data from evaluable participants. Evaluable participants are those participants who were enrolled and not replaced, or were the final enrolled replacement participant for another enrolled participant who met the criteria for replacement. | Posted | Number | participants | 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
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| Secondary | Pharmacokinetics: Tenofovir (TFV) Concentrations (log10 ng/mL) in Blood Plasma | Compare tenofovir concentrations in blood plasma among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. | Participant periods with tenofovir concentrations (log10 ng/mL) in blood plasma among evaluable participants. | Posted | Mean | Standard Deviation | log10 ng/mL | 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
|
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| Secondary | Pharmacokinetics: End Period Tenofovir (TFV) Concentrations (log10 ng/mg) in Rectal Tissue | Compare end period tenofovir concentrations in rectal tissue among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. | Participant end periods with tenofovir concentrations (log10 ng/mg) in rectal tissue among evaluable participants. | Posted | Mean | Standard Deviation | log10 ng/mg | 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
|
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| Secondary | Pharmacokinetics: Tenofovir (TFV) Concentrations (log10 ng/mg) in Rectal Sponge | Compare tenofovir concentrations in rectal sponge specimens among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. | Participant periods with tenofovir concentrations (log10 ng/mg) in rectal sponge specimens among evaluable participants. | Posted | Mean | Standard Deviation | log10 ng/mg | 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
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| Secondary | Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mL) in Blood Plasma | Compare emtricitabine concentrations in blood plasma among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. | Participant periods with emtricitabine (FTC) concentrations (log10 ng/mL) in blood plasma among evaluable participants. | Posted | Mean | Standard Deviation | log10 ng/mL | 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
|
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| Secondary | Pharmacokinetics: End Period Emtricitabine (FTC) Concentrations (log10 ng/mg) in Rectal Tissue | Compare end period emtricitabine concentrations in rectal tissue among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. | Participant end periods with emtricitabine (FTC) concentrations (log10 ng/mg) in rectal tissue among evaluable participants. | Posted | Mean | Standard Deviation | log10 ng/mg | 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
|
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| Secondary | Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mg) in Rectal Sponge | Compare emtricitabine concentrations in rectal sponge among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. | Participant periods with emtricitabine (FTC) concentrations (log10 ng/mg) in rectal sponge specimens among evaluable participants. | Posted | Mean | Standard Deviation | log10 ng/mg | 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
|
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| Secondary | Pharmacokinetics: End Period Tenofovir-Diphosphate (TFV-DP) Concentrations (log10 ng/mg) in Rectal Tissue | Compare end period tenofovir-diphosphate (TFV-DP) concentrations in rectal tissue among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. | Participant end periods with tenofovir-diphosphate (TFV-DP) concentrations (log10 ng/mg) in rectal tissue among evaluable participants. | Posted | Mean | Standard Deviation | log10 ng/mg | 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
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| Secondary | Adherence: Percentage of Prescribed Doses Taken Orally or Administered Rectally in an 8-week Period | Compare percentage of prescribed doses taken orally or administered rectally in an 8-week period based on the Final Converged Rates. Final Converged Rates were measured first via self-report through Short Message Service (SMS). The clinic staff also reported the most likely number of doses taken. Finally, the MTN Behavioral Research Working Group (BRWG) provided the final estimate of the number of doses taken for each participant for each period based on self-report, staff estimates and PK testing results. Note that these final judgement data are missing if PK results are missing. | Evaluable participants with Final Converged Rates of prescribed doses. | Posted | Count of Participants | Participants | 27 weeks (three 8-week product use periods with 1-week washout periods between them) |
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| Other Pre-specified | Pharmacodynamics | To characterize pharmacodynamic responses following oral and rectal exposure to antiretroviral drugs | Not Posted | 27 weeks (three 8-week product use periods with 1-week washout periods between them) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Mucosal Immunity | To characterize changes in mucosal immunity between baseline and the end of the daily FTC/TDF and TFV RG 1% gel product use | Not Posted | 27 weeks (three 8-week product use periods with 1-week washout periods between them) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Correlation Between PK and Adherence | To assess correlation of PK with adherence measures | Not Posted | 27 weeks (three 8-week product use periods with 1-week washout periods between them) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Factors Associated With Adherence | To identify factors associated with product adherence and whether they differ by product used (FTC/TDF or TFV RG 1% gel) or regimen (daily use or RAI-associated use) | Not Posted | 27 weeks (three 8-week product use periods with 1-week washout periods between them) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Sexual Activity and Condom Use | To examine whether sexual activity or condom use varies by product used | Not Posted | 27 weeks (three 8-week product use periods with 1-week washout periods between them) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Product Sharing | To determine the level of sharing of study products with non-participants and to assess with whom products are shared | Not Posted | 27 weeks (three 8-week product use periods with 1-week washout periods between them) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Problem Practices | To determine the prevalence of behavioral practices associated with anal intercourse that may affect microbicide use | Not Posted | 27 weeks (three 8-week product use periods with 1-week washout periods between them) | Participants |
27 weeks (three 8-week product use periods with 1-week washout periods between them)
AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Product 1 | Oral (Daily FTC/TDF) | 1 | 192 | 85 | 192 | ||
| EG001 | Product 2 | Rectal (Daily TFV RG 1% gel) | 2 | 192 | 103 | 192 | ||
| EG002 | Product 3 | Rectal (RAI-associated TFV RG 1% gel) | 0 | 191 | 87 | 191 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalisation | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Anorectal discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Defaecation urgency | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Gastrointestinal mucosa hyperaemia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Proctalgia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Rectal tenesmus | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Fatigue | General disorders | MedDRA | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Proctitis chlamydial | Infections and infestations | MedDRA | Systematic Assessment |
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| Proctitis gonococcal | Infections and infestations | MedDRA | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ross D. Cranston, MD, FRCP | Division of Infectious Diseases - UPMC | 412-383-2054 | rdc27@pitt.edu |
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D005782 | Gels |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| 20-24 |
|
| 25-29 |
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| 30-34 |
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| 35-39 |
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| 40-44 |
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| 45-49 |
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| 50+ |
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| Woman |
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| Transgender/Transwoman |
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| Other |
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| Refuse to answer |
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| No |
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| primary school, not complete |
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| primary school, complete |
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| secondary school, not complete |
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| secondary school, complete |
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| attended college or university |
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| Bisexual |
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| Straight/Heterosexual |
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| Other |
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| Refuse to answer |
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| Peru |
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| South Africa |
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| Thailand |
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| U.S.A. |
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| Asian |
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| Mixed |
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| Black |
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| Indigenous |
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| Other |
|
| Asian |
|
| Mixed |
|
| Black |
|
| Indigenous |
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| Other |
|
| White |
|
| Zulu |
|
| Xhosa |
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| Indian |
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| Colored |
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| Other |
|
| Mixed |
|
| Thai |
|
| Chinese |
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| Other |
|
| Asian |
|
| Mixed |
|
| Black/African-American |
|
| American Indian/Alaska Native |
|
| Native-Hawaiian or other Pacific Islander |
|
| Other |
|
| Since some participants have more than one safety event per period of treatment regimen, a Generalized Estimating Equation (GEE) model with a Poisson (log) link, exchangeable correlation structure, and robust standard errors were used. | Generalized Estimating Equation (GEE) | 0.43 | Risk Ratio (RR) | 0.88 | 2-Sided | 95 | 0.64 | 1.21 | It shows the rate ratio (RR) based on a GEE model comparing the RAI Rectal regimen with the Oral regimen and controlling for period in the model. | Superiority or Other (legacy) |
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| Units | Counts |
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| Participants |
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