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| ID | Type | Description | Link |
|---|---|---|---|
| 38591 | Registry Identifier | DAIDS-ES Registry Number |
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The purpose of this study is to evaluate the safety and drug detection of the dapivirine vaginal ring and oral Truvada in breastfeeding mother-infant pairs.
This study will evaluate the safety and drug detection of the dapivirine (DPV) vaginal ring (VR) and oral Truvada in breastfeeding mother-infant pairs.
Mother-infant pairs will be randomly assigned to receive either the DPV VR or oral Truvada. Mothers randomized to the DPV VR will use the VR continuously for approximately one month (4 weeks), replacing the VR each month for approximately three months (12 weeks). Mothers using the Truvada tablet will take one tablet by mouth daily for approximately three months (12 weeks).
Study visits will occur at Day 0, Weeks 1 and 2, and Months 1, 2, 3, and 3.5. Study visits may include behavioral assessments; product acceptability assessments; infant feeding assessments; physical examinations; blood, urine, and breast milk collection; and pelvic examination and specimen collection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 | Experimental | Mothers will use one DPV VR continuously for approximately one month, replacing the DPV VR each month for approximately three months. |
|
| Group B: Truvada Tablet | Experimental | Mothers will take one Truvada oral tablet daily for approximately three months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapivirine (DPV) Vaginal Ring (VR)-004 | Drug | Vaginal ring containing 25 mg of DPV |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Mother Participants With Serious Adverse Events (SAEs) Including Maternal Deaths in Both Study Arms | As defined by the Manual for Expedited Reporting of Adverse Events to the Division of AIDS (DAIDS) (Version 2.0, January 2010) | Measured through Month 3.5 |
| Number of Mother Participants With Grade 3 or Higher Adverse Events (AEs) in Both Study Arms | As defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 and/or Addendum 1 (Female Genital Grading Table for Use in Microbicide Studies [Dated November 2007]) | Measured through Month 3.5 |
| Number of Infant Participants With SAEs Including Infant Deaths in Both Study Arms | As defined by the Manual for Expedited Reporting of Adverse Events to DAIDS (Version 2.0, January 2010) | Measured through Month 3.5 |
| Number of Infant Participants With Grade 3 or Higher AEs in Both Study Arms | As defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 | Measured through Month 3.5 |
| Number and Proportion of Mothers With Detectable Plasma Dapivirine (DPV) Concentrations | This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from mother participants. DPV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For DPV concentration in plasma, the LLOQ is 20 pg/ml. The infant endpoint is included as a separate section below. | Measured through Month 3.5 |
| Number and Proportion of Mothers With Detectable Emtricitabine Triphosphate (FTC-TP) Concentrations |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Mothers Non-adherent to Study Product for Each Month of Product Use by Study Product | The number and proportion of mother's visits with drug concentration indicative of non-adherence (no use) are reported by study month. Non-adherence is measured by residual drug in returned VRs for mothers assigned the DPV VR arm and by TFV-DP concentrations in dried blood spot specimens for mothers assigned the Truvada tablet arm. For mothers on the DPV VR arm, no use is defined as residual DPV concentration in the returned VRs <= 0.9mg/month. For mothers on the Truvada arm, no use is defined as TFV-DP concentrations < 16.6 fmol/punch. Only mother participants are included in this endpoint since infants did not directly use study product in this study. |
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Inclusion Criteria:
Inclusion Criteria - Mother
Participant mothers must meet all the following criteria to be eligible for inclusion in the study:
Age 18 years or older at Screening, as verified per site Standard Operating Procedures (SOPs).
At Enrollment, between 6 to 12 weeks postpartum (verified by birth records and/or similar supportive documentation and defined as between 42 - 84 days after delivery, inclusive).
By participant report at Screening and Enrollment, currently exclusively breastfeeding one infant and willing and able to continue exclusively breastfeeding that infant for the duration of their participation in the study.
Consistently using an effective method of contraception per participant report at Enrollment, and intending to continue use of an effective method for the duration of study participation. Effective methods include contraceptive implants, intrauterine device, injectable progestin, oral contraceptive pills, and surgical sterilization.
Able and willing to comply with all study requirements and complete all study procedures.
Able and willing to provide the following:
Intention to stay within study catchment area for study duration and willingness to give adequate locator information, as defined in site SOPs.
At Screening and Enrollment, HIV-uninfected based on HIV testing performed by study staff (per algorithm in the study protocol).
At Screening and Enrollment, willing to be randomized at time of enrollment to either of the study products, and to continue study product use for at least 12 weeks.
Inclusion Criteria - Infant
Each mother eligible for MTN-043 will be asked to provide written informed consent for herself and her infant to participate in the study if the infant meets the following criteria:
At Screening and Enrollment, infant is exclusively breastfed.
At Screening and Enrollment, the infant is generally healthy, according to the judgment of the investigator of record (IoR)/designee.
At Enrollment, the infant is between the ages of 6 and 12 weeks postpartum (verified by birth records and/or similar supportive documentation with age defined as between 42 - 84 days after delivery, inclusive).
Exclusion Criteria:
Exclusion Criteria - Mother
Mothers who meet any of the following criteria will be excluded from the study:
At Screening or Enrollment, breastfeeding infant ineligible for enrollment in the study.
At Screening or Enrollment, participant reports any of the following:
At Screening or Enrollment, has a positive HIV test.
At Screening or Enrollment, Grade 2 or higher breast or genitourinary findings.
At Screening or Enrollment, has a positive urinary pregnancy test.
At Screening, has any of the following laboratory abnormalities:
Diagnosed with urinary tract infection (UTI), pelvic inflammatory disease (PID), sexually transmitted infection (STI) or reproductive tract infection (RTI), requiring treatment per World Health Organization (WHO) Guidelines.
As determined by the IoR/designee, any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease.
Has any other condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
At Enrollment, participant reports any of the following:
Exclusion Criteria - Infants
Has any condition that, in the opinion of the IoR/designee, would preclude eligibility, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
At Enrollment, according to the report of the mother, any of the following apply for the infant:
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| Name | Affiliation | Role |
|---|---|---|
| Maxensia Owor, MBChB, MMed, MPH | MU-JHU CARE | Study Chair |
| Lisa Noguchi, PhD, CNM | Johns Hopkins Bloomberg School of Public Health | Study Chair |
| Jen Balkus, PhD, MPH | Hans Rosling Center for Population Health | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blantyre CRS (Johns Hopkins Research Project/College of Medicine) | Blantyre | Malawi | ||||
| Wits RHI Shandukani Research Centre CRS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39954697 | Derived | Noguchi LM, Owor M, Mgodi NM, Gati Mirembe B, Dadabhai S, Horne E, Gundacker H, Richardson BA, Bunge K, Scheckter R, Song M, Marzinke MA, Anderson PL, Livant E, Jacobson C, Piper JM, Chakhtoura N, Hillier SL, Balkus JE; MTN-043 Study Team. Safety and drug quantification of the dapivirine vaginal ring and oral pre-exposure prophylaxis in breastfeeding mother-infant pairs (MTN-043): a phase 3B, open-label, randomised trial. Lancet HIV. 2025 Mar;12(3):e180-e190. doi: 10.1016/S2352-3018(24)00306-0. Epub 2025 Feb 12. |
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Individual participant data will be made available to researchers upon request. The IPD to be shared will be negotiated with the researchers
within 8 weeks of request approval and to be available as long as needed.
MTN-043 study management team approval
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197 mother-infant pairs were enrolled in the study. When the mothers are enrolled and discontinued from the study, their infants are enrolled or discontinued.
197 mother-infant pairs were enrolled in 4 African countries from September 2020 until July 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 | Mothers will use one DPV VR continuously for approximately one month, replacing the DPV VR each month for approximately three months. Dapivirine (DPV) Vaginal Ring (VR)-004: Vaginal ring containing 25 mg of DPV |
| FG001 | Group B: Truvada Tablet |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 24, 2019 | Apr 7, 2023 |
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| Truvada Tablet | Drug | Oral tablet containing 200 mg emtricitabine (FTC)/300 mg tenofovir disoproxil fumarate (TDF) |
|
|
This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. FTC-TP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For FTC-TP concentration in DBS specimens, the LLOQ is 0.125 pmol/punch. The infant endpoint is included as a separate section below. |
| Measured through Month 3.5 |
| Number and Proportion of Mothers With Detectable Tenofovir Diphosphate (TFV-DP) Concentrations | This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. TFV-DP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For TFV-DP concentrations, the LLOQ is 31.3 fmol/punch. The infant endpoint is included as a separate section below. | Measured through Month 3.5 |
| Number and Proportion of Mothers With Detectable Breastmilk DPV Concentrations | This endpoint is based on DPV concentration laboratory results from evaluable breastmilk specimens from mother participants. DPV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For DPV concentration in breastmilk, the LLOQ is 10 pg/ml. | Measured through Month 3.5 |
| Number and Proportion of Mothers With Detectable Breastmilk FTC Concentrations | This endpoint is based on FTC concentration laboratory results from evaluable breastmilk specimens from mother participants. FTC concentrations above the lower limit of quantification (LLOQ) are considered detectable. For FTC concentrations in breastmilk, the LLOQ is 5 mg/ml. | Measured through Month 3.5 |
| Number and Proportion of Mothers With Detectable Breastmilk TFV Concentrations | This endpoint is based on TFV concentration laboratory results from evaluable breastmilk specimens from mother participants. TFV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For TFV concentrations in breastmilk, the LLOQ is 1 ng/ml. | Measured through Month 3.5 |
| Number and Proportion of Infants With Detectable Plasma DPV Concentrations | This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from infant participants. DPV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For DPV concentration in plasma, the LLOQ is 20 pg/ml. The mother endpoints are included as separate sections above. | Measured through Month 3.5 |
| Number and Proportion of Infants With Detectable FTC-TP Concentrations | This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. FTC-TP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For FTC-TP concentrations from DBS specimens, the LLOQ is 0.125 pmol/punch. The mother endpoints are included as separate sections above. | Measured through Month 3.5 |
| Number and Proportion of Infants With Detectable TFV-DP Concentrations | This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. TFV-DP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For TFV-DP concentrations from DBS specimens, the LLOQ is 31.3 fmol/punch. The mother endpoints are included as separate sections above. | Measured through Month 3.5 |
| Geometric Mean of Maternal DPV Concentrations From Plasma by Visit | This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the DPV VR arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (20pg/ml). The infant endpoints for geometric mean concentrations are included as separate sections below. | Measured through Month 3.5 |
| Geometric Mean of Maternal FTC-TP Concentrations by Visit | This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (0.125 pmol/punch). The infant endpoints for geometric mean concentrations are included as separate sections below. | Measured through Month 3.5 |
| Geometric Mean of Maternal TFV-DP Concentrations by Visit | This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (31.3 fmol/punch). The infant endpoints for geometric mean concentrations are included as separate sections below. | Measured through Month 3.5 |
| Geometric Mean of Maternal DPV Concentrations From Breastmilk by Visit | This endpoint is based on DPV concentration laboratory results from evaluable breastmilk specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the DPV VR arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (10pg/ml). The infant endpoints for geometric mean concentrations are included as separate sections below. | Measured through Month 3.5 |
| Geometric Mean of Maternal FTC Concentrations From Breastmilk by Visit | This endpoint is based on FTC concentration laboratory results from evaluable breastmilk specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (5 mg/ml). The infant endpoints for geometric mean concentrations are included as separate sections below. | Measured through Month 3.5 |
| Geometric Mean of Maternal TFV Concentrations From Breastmilk by Visit | This endpoint is based on TFV concentration laboratory results from evaluable breastmilk specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (1 ng/ml). The infant endpoints for geometric mean concentrations are included as separate sections below. | Measured through Month 3.5 |
| Geometric Mean of Infant DPV Concentrations From Plasma by Visit | This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from infant participants. The geometric mean is summarized by study visit and includes only infants of mothers randomized to the DPV VR arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (20pg/ml). The mother endpoints for geometric mean concentrations are included as separate sections above. | Measured through Month 3.5 |
| Geometric Mean of Infant FTC-TP Concentration by Visit | This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. The geometric mean is summarized by study visit and includes only infants of mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (0.125 pmol/punch). The mother endpoints for geometric mean concentrations are included as separate sections above. | Measured through Month 3.5 |
| Geometric Mean of Infant TFV-DP Concentrations by Visit | This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. The geometric mean is summarized by study visit and includes only infants of mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (31.3 fmol/punch). The mother endpoints for geometric mean concentrations are included as separate sections above. | Measured through Month 3.5 |
| Measured through Month 3 |
| Residual Drug Levels in Returned VRs | The residual DPV concentrations from the returned VRs are summarized. | Measured through Month 3.5 |
| Participant Willingness to Use Their Assigned Study Products During Breastfeeding in the Future (Y/N) | Based on participant report to the question "Would you be willing to use the study product for HIV prevention while breastfeeding in the future?" | Measured through Month 3.5 |
| Proportion of Participants Who Find Their Study Product to be at Least as Acceptable as Other HIV Prevention Methods | Based on participant report on the question "Overall, how much did you like using the study product?" on the Product End Use Visit Behavioral Assessment. | Measured through Month 3.5 |
| Johannesburg |
| Gauteng |
| 2001 |
| South Africa |
| MU-JHU Research Collaboration (MUJHU CARE LTD) CRS | Kampala | Uganda |
| Zengeza CRS | Chitungwiza | Mashonaland East Province | Zimbabwe |
Mothers will take one Truvada oral tablet daily for approximately three months. Truvada Tablet: Oral tablet containing 200 mg emtricitabine (FTC)/300 mg tenofovir disoproxil fumarate (TDF) |
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| Mothers |
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| Infants |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 | Adverse Events for Mothers randomized to the DPV VR study arm. |
| BG001 | Mothers - Group B: Truvada Tablet | Adverse Events for Mothers randomized to the Truvada oral tablet study arm. |
| BG002 | Infants - Group A: DPV VR | Adverse Events for Infants of Mothers randomized to the DPV VR study arm. |
| BG003 | Infants - Group B: Truvada Tablet | Adverse Events for Infants of Mothers randomized to the Truvada oral tablet study arm. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Only mothers are included in this baseline measure since mother age is summarized in years. Infants age is summarized below in weeks. | Median | Full Range | years |
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| Age, Continuous | Only infants are included in this baseline measure since infant age is summarized in weeks. | Median | Full Range | weeks |
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| Age, Customized | Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks. | Count of Participants | Participants |
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| Age, Customized | Only infants are included in this baseline measure since infant age is categorized in weeks. | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Number of Mother Participants With Serious Adverse Events (SAEs) Including Maternal Deaths in Both Study Arms | As defined by the Manual for Expedited Reporting of Adverse Events to the Division of AIDS (DAIDS) (Version 2.0, January 2010) | All Mothers received study product and are used in the analysis population. | Posted | Count of Participants | Participants | Measured through Month 3.5 |
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| Primary | Number of Mother Participants With Grade 3 or Higher Adverse Events (AEs) in Both Study Arms | As defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 and/or Addendum 1 (Female Genital Grading Table for Use in Microbicide Studies [Dated November 2007]) | All enrolled mothers received study product. | Posted | Count of Participants | Participants | Measured through Month 3.5 |
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| Primary | Number of Infant Participants With SAEs Including Infant Deaths in Both Study Arms | As defined by the Manual for Expedited Reporting of Adverse Events to DAIDS (Version 2.0, January 2010) | All infants were exposed to study product through mothers' breastmilk. All enrolled mothers received study product. | Posted | Count of Participants | Participants | Measured through Month 3.5 |
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| Primary | Number of Infant Participants With Grade 3 or Higher AEs in Both Study Arms | As defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 | Infants were exposed to study product through breastmilk. All enrolled mothers received study product. | Posted | Count of Participants | Participants | Measured through Month 3.5 |
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| Primary | Number and Proportion of Mothers With Detectable Plasma Dapivirine (DPV) Concentrations | This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from mother participants. DPV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For DPV concentration in plasma, the LLOQ is 20 pg/ml. The infant endpoint is included as a separate section below. | This endpoint includes the mothers randomized to the DPV VR arm with available and evaluable plasma specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes mothers with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Infant results are in a separate section below. | Posted | Count of Participants | Participants | Measured through Month 3.5 |
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| Primary | Number and Proportion of Mothers With Detectable Emtricitabine Triphosphate (FTC-TP) Concentrations | This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. FTC-TP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For FTC-TP concentration in DBS specimens, the LLOQ is 0.125 pmol/punch. The infant endpoint is included as a separate section below. | This endpoint includes the mothers randomized to the Truvada arm with available and evaluable DBS specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes mothers with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Infant results are in a separate section below. | Posted | Count of Participants | Participants | Measured through Month 3.5 |
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| Primary | Number and Proportion of Mothers With Detectable Tenofovir Diphosphate (TFV-DP) Concentrations | This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. TFV-DP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For TFV-DP concentrations, the LLOQ is 31.3 fmol/punch. The infant endpoint is included as a separate section below. | This endpoint includes the mothers randomized to the Truvada arm with available and evaluable DBS specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes mothers with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Infant results are in a separate section below. | Posted | Count of Participants | Participants | Measured through Month 3.5 |
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| Primary | Number and Proportion of Mothers With Detectable Breastmilk DPV Concentrations | This endpoint is based on DPV concentration laboratory results from evaluable breastmilk specimens from mother participants. DPV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For DPV concentration in breastmilk, the LLOQ is 10 pg/ml. | This endpoint includes the mothers randomized to the DPV VR arm with available and evaluable breastmilk specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes mothers with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Infants are not included in this population. | Posted | Count of Participants | Participants | Measured through Month 3.5 |
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| Primary | Number and Proportion of Mothers With Detectable Breastmilk FTC Concentrations | This endpoint is based on FTC concentration laboratory results from evaluable breastmilk specimens from mother participants. FTC concentrations above the lower limit of quantification (LLOQ) are considered detectable. For FTC concentrations in breastmilk, the LLOQ is 5 mg/ml. | This endpoint includes the mothers randomized to the Truvada arm with available and evaluable breastmilk specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes mothers with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Infants are not included in this population. | Posted | Count of Participants | Participants | Measured through Month 3.5 |
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| Primary | Number and Proportion of Mothers With Detectable Breastmilk TFV Concentrations | This endpoint is based on TFV concentration laboratory results from evaluable breastmilk specimens from mother participants. TFV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For TFV concentrations in breastmilk, the LLOQ is 1 ng/ml. | This endpoint includes the mothers randomized to the Truvada arm with available and evaluable breastmilk specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes mothers with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Infants are not included in this population. | Posted | Count of Participants | Participants | Measured through Month 3.5 |
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| Primary | Number and Proportion of Infants With Detectable Plasma DPV Concentrations | This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from infant participants. DPV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For DPV concentration in plasma, the LLOQ is 20 pg/ml. The mother endpoints are included as separate sections above. | This endpoint includes the infants of mothers randomized to the DPV VR arm with available and evaluable plasma specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes infants with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Mother results are in a separate section above. | Posted | Count of Participants | Participants | Measured through Month 3.5 |
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| Primary | Number and Proportion of Infants With Detectable FTC-TP Concentrations | This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. FTC-TP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For FTC-TP concentrations from DBS specimens, the LLOQ is 0.125 pmol/punch. The mother endpoints are included as separate sections above. | This endpoint includes the infants of mothers randomized to the Truvada arm with available and evaluable DBS specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes infants with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Mother results are in a separate section above. | Posted | Count of Participants | Participants | Measured through Month 3.5 |
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| Primary | Number and Proportion of Infants With Detectable TFV-DP Concentrations | This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. TFV-DP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For TFV-DP concentrations from DBS specimens, the LLOQ is 31.3 fmol/punch. The mother endpoints are included as separate sections above. | This endpoint includes the infants of mothers randomized to the Truvada arm with available and evaluable DBS specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes infants with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Mother results are in a separate section above. | Posted | Count of Participants | Participants | Measured through Month 3.5 |
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| Primary | Geometric Mean of Maternal DPV Concentrations From Plasma by Visit | This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the DPV VR arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (20pg/ml). The infant endpoints for geometric mean concentrations are included as separate sections below. | This endpoint includes the mothers randomized to the DPV VR arm with available and evaluable plasma specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes mothers with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Infant results are in a separate section below. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | Measured through Month 3.5 |
|
| |||||||||||||||||||||||||||||
| Primary | Geometric Mean of Maternal FTC-TP Concentrations by Visit | This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (0.125 pmol/punch). The infant endpoints for geometric mean concentrations are included as separate sections below. | This endpoint includes the mothers randomized to the Truvada arm with available and evaluable DBS specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes mothers with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Infant results are in a separate section below. | Posted | Geometric Mean | Geometric Coefficient of Variation | pmol/punch | Measured through Month 3.5 |
|
| |||||||||||||||||||||||||||||
| Primary | Geometric Mean of Maternal TFV-DP Concentrations by Visit | This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (31.3 fmol/punch). The infant endpoints for geometric mean concentrations are included as separate sections below. | This endpoint includes the mothers randomized to the Truvada arm with available and evaluable DBS specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes mothers with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Infant results are in a separate section below. | Posted | Geometric Mean | Geometric Coefficient of Variation | fmol/punch | Measured through Month 3.5 |
|
| |||||||||||||||||||||||||||||
| Primary | Geometric Mean of Maternal DPV Concentrations From Breastmilk by Visit | This endpoint is based on DPV concentration laboratory results from evaluable breastmilk specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the DPV VR arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (10pg/ml). The infant endpoints for geometric mean concentrations are included as separate sections below. | This endpoint includes the mothers randomized to the DPV VR arm with available and evaluable breastmilk specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes mothers with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Infant results are in a separate section below. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | Measured through Month 3.5 |
|
| |||||||||||||||||||||||||||||
| Primary | Geometric Mean of Maternal FTC Concentrations From Breastmilk by Visit | This endpoint is based on FTC concentration laboratory results from evaluable breastmilk specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (5 mg/ml). The infant endpoints for geometric mean concentrations are included as separate sections below. | This endpoint includes the mothers randomized to the Truvada arm with available and evaluable breastmilk specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes mothers with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Infant results are in a separate section below. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg/mL | Measured through Month 3.5 |
|
| |||||||||||||||||||||||||||||
| Primary | Geometric Mean of Maternal TFV Concentrations From Breastmilk by Visit | This endpoint is based on TFV concentration laboratory results from evaluable breastmilk specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (1 ng/ml). The infant endpoints for geometric mean concentrations are included as separate sections below. | This endpoint includes the mothers randomized to the Truvada arm with available and evaluable breastmilk specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes mothers with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Infant results are in a separate section below. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Measured through Month 3.5 |
|
| |||||||||||||||||||||||||||||
| Primary | Geometric Mean of Infant DPV Concentrations From Plasma by Visit | This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from infant participants. The geometric mean is summarized by study visit and includes only infants of mothers randomized to the DPV VR arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (20pg/ml). The mother endpoints for geometric mean concentrations are included as separate sections above. | This endpoint includes the infants of mothers randomized to the DPV VR arm with available and evaluable plasma specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes infants with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Mother results are in a separate section above. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | Measured through Month 3.5 |
|
| |||||||||||||||||||||||||||||
| Primary | Geometric Mean of Infant FTC-TP Concentration by Visit | This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. The geometric mean is summarized by study visit and includes only infants of mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (0.125 pmol/punch). The mother endpoints for geometric mean concentrations are included as separate sections above. | This endpoint includes the infants of mothers randomized to the Truvada arm with available and evaluable DBS specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes infants with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Mother results are in a separate section above. | Posted | Geometric Mean | Geometric Coefficient of Variation | pmol/punch | Measured through Month 3.5 |
|
| |||||||||||||||||||||||||||||
| Primary | Geometric Mean of Infant TFV-DP Concentrations by Visit | This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. The geometric mean is summarized by study visit and includes only infants of mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (31.3 fmol/punch). The mother endpoints for geometric mean concentrations are included as separate sections above. | This endpoint includes the infants of mothers randomized to the Truvada arm with available and evaluable DBS specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes infants with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Mother results are in a separate section above. | Posted | Geometric Mean | Geometric Coefficient of Variation | fmol/punch | Measured through Month 3.5 |
|
| |||||||||||||||||||||||||||||
| Secondary | The Number of Mothers Non-adherent to Study Product for Each Month of Product Use by Study Product | The number and proportion of mother's visits with drug concentration indicative of non-adherence (no use) are reported by study month. Non-adherence is measured by residual drug in returned VRs for mothers assigned the DPV VR arm and by TFV-DP concentrations in dried blood spot specimens for mothers assigned the Truvada tablet arm. For mothers on the DPV VR arm, no use is defined as residual DPV concentration in the returned VRs <= 0.9mg/month. For mothers on the Truvada arm, no use is defined as TFV-DP concentrations < 16.6 fmol/punch. Only mother participants are included in this endpoint since infants did not directly use study product in this study. | Only mother participants are included in this endpoint since infants did not directly use study product. The number of mothers analyzed includes mother participants with a returned/used vaginal ring that was successfully analyzed for residual drug concentration (evaluable) for Group A (DPV VR) and only those participants with an available and evaluable dried blood plot specimen for mothers in Group B (Truvada). Rings returned after the Month 3 Product Use End Visit (PUEV) are excluded. | Posted | Count of Participants | Participants | Measured through Month 3 |
| |||||||||||||||||||||||||||||||
| Secondary | Residual Drug Levels in Returned VRs | The residual DPV concentrations from the returned VRs are summarized. | The analysis population includes mothers with evaluable residual DPV concentrations from returned vaginal rings (VRs). Rings returned on or after the Month 3 visit are included in the Month 3 summary. | Posted | Median | Inter-Quartile Range | mg | Measured through Month 3.5 |
|
| |||||||||||||||||||||||||||||
| Secondary | Participant Willingness to Use Their Assigned Study Products During Breastfeeding in the Future (Y/N) | Based on participant report to the question "Would you be willing to use the study product for HIV prevention while breastfeeding in the future?" | The number of mothers analyzed includes all mothers who completed the Product End Use Visit Behavioral Assessment and responded to the willingness question. The count of participants who are willing, responded "Yes" to the question. | Posted | Count of Participants | Participants | Measured through Month 3.5 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants Who Find Their Study Product to be at Least as Acceptable as Other HIV Prevention Methods | Based on participant report on the question "Overall, how much did you like using the study product?" on the Product End Use Visit Behavioral Assessment. | The number of mothers analyzed included those who completed the Product End Use Visit Behavioral Assessment and responded to the acceptability question. The mothers who answered "Like very much" or "Like" are included in the total who find the study product acceptable. | Posted | Count of Participants | Participants | Measured through Month 3.5 |
|
|
The participant is followed for adverse events during study follow-up which was scheduled to be up to 14 weeks (98 days).
The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. In addition, these events are summarized using the specific Adverse Event Term for the event.
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 | Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 | Adverse Events for Mothers randomized to the DPV VR study arm. | 0 | 148 | 2 | 148 | 92 | 148 |
| EG001 | Mothers - Group B: Truvada Tablet | Adverse Events for Mothers randomized to the Truvada oral tablet study arm. | 0 | 49 | 0 | 49 | 35 | 49 |
| EG002 | Infants - Group A: DPV VR | Adverse Events for Infants of Mothers randomized to the DPV VR study arm. | 0 | 148 | 4 | 148 | 112 | 148 |
| EG003 | Infants - Group B: Truvada Tablet | Adverse Events for Infants of Mothers randomized to the Truvada oral tablet study arm. | 0 | 49 | 0 | 49 | 32 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any Event in SOC | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Appendiceal abscess | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Dysentery | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Any Event in SOC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Any Event in SOC | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Any Event in SOC | Congenital, familial and genetic disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Micropenis | Congenital, familial and genetic disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Any Event in SOC | Ear and labyrinth disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Excessive cerumen production | Ear and labyrinth disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Amblyopia | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Any Event in SOC | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Eye inflammation | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pterygium | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Any Event in SOC | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Gingival cyst | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Any Event in SOC | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Any Event in SOC | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abscess rupture | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Adenoiditis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Any Event in SOC | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Asymptomatic COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Bacterial vaginosis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Conjunctivitis bacterial | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Gastroenteritis bacterial | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Mastitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pharyngitis bacterial | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Skin bacterial infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Tinea faciei | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Tinea infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Tinea manuum | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Vaccination site abscess | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Viral rash | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Vulvovaginitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Any Event in SOC | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Chest injury | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Ear injury | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Any Event in SOC | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Any Event in SOC | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Weight gain poor | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Any Event in SOC | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Short stature | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Any Event in SOC | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Any Event in SOC | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Glycosuria | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Any Event in SOC | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cervix erythema | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspareunia | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Genital paraesthesia | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Intermenstrual bleeding | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vaginal odour | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vulvovaginal discomfort | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Any Event in SOC | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Any Event in SOC | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Any Event in SOC | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jen Balkus | Hans Rosling Center for Population Health | 260 616 6614 | jbalkus@uw.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 4, 2022 | Apr 6, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C481671 | Dapivirine |
| D003274 | Contraceptive Devices, Female |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D003273 | Contraceptive Devices |
| D004864 | Equipment and Supplies |
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
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| Uganda |
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| Zimbabwe |
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Non-adherence of Mothers randomized to the Truvada oral tablet study arm. |
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