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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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The purpose of this study is to determine whether the use of rectal lubricants can affect how well the medication, Truvada, will work to prevent infection with HIV when someone is exposed to HIV in the rectum.
Men who have sex with men (MSM) continue to be disproportionately affected by HIV. The majority of HIV infections among MSM occur through exposure to the rectal mucosa during receptive anal intercourse (RAI). During RAI, many MSM will use lubricants, which can potentially cause mucosal inflammation and damage. A new HIV prevention intervention, called pre-exposure prophylaxis (PrEP), recommends that MSM at risk of HIV infection take a daily anti-HIV medication called Truvada (tenofovir/emtricitabine) which is highly effective. However, it is not known if the use of lubricant during RAI will interfere with the efficacy of PrEP for HIV prevention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rectal Gel Lubricant | Active Comparator | Subjects will insert 5 mL of lubricant in rectum for seven consecutive days |
|
| Truvada | Active Comparator | Subjects will take one Truvada tablet orally for seven consecutive days |
|
| Rectal Gel Lubricant + Truvada | Active Comparator | Subjects will insert 5 mL of lubricant in rectum and take one Truvada tablet orally for seven consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Truvada | Drug | Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median Percentage of CD4 Positive T-Cells | HIV target cell availability will be assessed by the median percentage of CD4+ T cells that express HIV co-receptor CCR5 as measured prior to product use and on day 8 after product use. | Baseline, Post-Intervention (Day 8) |
| Median Cumulative Amount of p24 | The median cumulative amount of p24 produced in a rectal explant challenge assay as measured by ELISA from participants prior to product use and on day 8 after product use. | Baseline, Post-Intervention (Day 8) |
| Measure | Description | Time Frame |
|---|---|---|
| Median Plasma Emtricitabine (FTC) Concentration | Median plasma FTC concentration as measured in ng/ml prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. | Post-Intervention (Day 8) |
| Median Plasma Tenofovir (TDF) Concentration |
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Inclusion Criteria:
Exclusion Criteria:
History of inflammatory bowel disease or other inflammatory, infiltrative, infectious or vascular condition involving the lower gastrointestinal tract that, in the judgment of the investigators, may be worsened by study procedures or may significantly distort the anatomy of the distal large bowel
Significant laboratory abnormalities at baseline visit for rectal biopsies, including but not limited to:
Any known medical condition that, in the judgment of the investigators, increases the risk of local or systemic complications of endoscopic procedures or pelvic examination, including but not limited to:
Continued need for, or use during the 14 days prior to enrollment, of the following medications:
Continued need for, or use during the 90 days prior to enrollment, of the following medications:
Intent to use HIV antiretroviral PrEP during the study, outside of the study procedures
Symptoms of an untreated rectal sexually transmitted infection (e.g. rectal pain, discharge, bleeding, etc.)
Current use of hormonal therapy
Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements
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| Name | Affiliation | Role |
|---|---|---|
| Colleen Kelley, MD/MPH | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hope Clinic of of Emory University | Decatur | Georgia | 30030 | United States |
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Of the 86 subjects consented for study participation, 76 were randomized to a study intervention.
Participants were recruited March 2015 through November 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rectal Gel Lubricant | Subjects inserted 5 mL of lubricant in rectum for seven consecutive days. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator. |
| FG001 | Truvada | Subjects took one Truvada tablet orally for seven consecutive days. Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally. |
| FG002 | Rectal Gel Lubricant + Truvada | Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who began a study intervention and completed all study visits.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rectal Gel Lubricant | Subjects inserted 5 mL of lubricant in rectum for seven consecutive days Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator. |
| BG001 | Truvada |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Median Percentage of CD4 Positive T-Cells | HIV target cell availability will be assessed by the median percentage of CD4+ T cells that express HIV co-receptor CCR5 as measured prior to product use and on day 8 after product use. | The analysis population includes participants for whom the assay could be accurately performed. Data were not available for analysis in the case of an insufficient sample to perform this assay, poor performance of the assay, or technical issues in the laboratory. | Posted | Median | Inter-Quartile Range | percentage positive T-cells | Baseline, Post-Intervention (Day 8) |
|
Adverse events were collected throughout study duration (1 year and 7 months).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rectal Gel Lubricant | Subjects inserted 5 mL of lubricant in rectum for seven consecutive days. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erectile Dysfunction | Reproductive system and breast disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Colleen Kelley | Emory University | 404-712-1823 | colleen.kelley@emory.edu |
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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 | Sep 26, 2016 | Jan 19, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 19, 2018 | Jan 19, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| D000068679 | Emtricitabine |
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
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|
| Gel lubricant | Device | Five ml of an over the counter sexual lubricant will be dispensed using an applicator. |
|
Median plasma TDF concentration as measured in ng/ml prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. |
| Post-Intervention (Day 8) |
| Median Rectal Secretion Emtricitabine (FTC) Concentration | Median rectal secretions FTC concentrations as measured in ng/swab prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. | Post-Intervention (Day 8) |
| Median Rectal Secretion Tenofovir (TDF) Concentration | Median rectal secretions TDF concentrations as measured in ng/swab prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. | Post-Intervention (Day 8) |
| Median Peripheral Blood Mononuclear Cell (PBMC) Emtricitabine (FTC) Concentration | Median blood PBMC FTC concentrations as measured in fmol/million cells prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. | Post-Intervention (Day 8) |
| Median Peripheral Blood Mononuclear Cell (PBMC) Tenofovir (TDF) Concentration | Median blood PBMC TDF concentrations as measured in fmol/million cells prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. | Post-Intervention (Day 8) |
| Median Rectal Tissue Emtricitabine (FTC) Concentration | Median rectal tissue FTC concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. | Post-Intervention (Day 8) |
| Median Rectal Tissue Tenofovir (TDF) Concentration | Median rectal tissue TDF concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. | Post-Intervention (Day 8) |
| Median Rectal Tissue Deoxyadenosine Triphosphate (dATP) Concentration | Median rectal tissue dATP concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. | Baseline, Post-Intervention (Day 8) |
| Median Rectal Tissue Deoxycytidine Triphosphate (dCTP) Concentration | Median rectal tissue dCTP concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. | Baseline, Post-Intervention (Day 8) |
| Median Peripheral Blood Mononuclear Cell (PBMC) Deoxyadenosine Triphosphate (dATP) Concentration | Median blood dATP concentrations as measured in fmol/million cells prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. | Baseline, Post-Intervention (Day 8) |
| Lost to Follow-up |
|
Subjects took one Truvada tablet orally for seven consecutive days
Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.
| BG002 | Rectal Gel Lubricant + Truvada | Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Truvada |
Subjects took one Truvada tablet orally for seven consecutive days. Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally. |
| OG002 | Rectal Gel Lubricant + Truvada | Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator. |
|
|
| Primary | Median Cumulative Amount of p24 | The median cumulative amount of p24 produced in a rectal explant challenge assay as measured by ELISA from participants prior to product use and on day 8 after product use. | Number of participants who provided a viable sample. | Posted | Median | Inter-Quartile Range | pg/mL | Baseline, Post-Intervention (Day 8) |
|
|
|
| Secondary | Median Plasma Emtricitabine (FTC) Concentration | Median plasma FTC concentration as measured in ng/ml prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. | Number of participants who provided a viable sample. | Posted | Median | Inter-Quartile Range | ng/ml | Post-Intervention (Day 8) |
|
|
|
| Secondary | Median Plasma Tenofovir (TDF) Concentration | Median plasma TDF concentration as measured in ng/ml prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. | Number of participants who provided a viable sample. | Posted | Median | Inter-Quartile Range | ng/ml | Post-Intervention (Day 8) |
|
|
|
| Secondary | Median Rectal Secretion Emtricitabine (FTC) Concentration | Median rectal secretions FTC concentrations as measured in ng/swab prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. | Number of participants who provided a viable sample. | Posted | Median | Inter-Quartile Range | ng/swab | Post-Intervention (Day 8) |
|
|
|
| Secondary | Median Rectal Secretion Tenofovir (TDF) Concentration | Median rectal secretions TDF concentrations as measured in ng/swab prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. | Number of participants who provided a viable sample. | Posted | Median | Inter-Quartile Range | ng/swab | Post-Intervention (Day 8) |
|
|
|
| Secondary | Median Peripheral Blood Mononuclear Cell (PBMC) Emtricitabine (FTC) Concentration | Median blood PBMC FTC concentrations as measured in fmol/million cells prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. | Number of participants who provided a viable sample. | Posted | Median | Inter-Quartile Range | fmol/million cells | Post-Intervention (Day 8) |
|
|
|
| Secondary | Median Peripheral Blood Mononuclear Cell (PBMC) Tenofovir (TDF) Concentration | Median blood PBMC TDF concentrations as measured in fmol/million cells prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. | Number of participants who provided a viable sample. | Posted | Median | Inter-Quartile Range | fmol/million cells | Post-Intervention (Day 8) |
|
|
|
| Secondary | Median Rectal Tissue Emtricitabine (FTC) Concentration | Median rectal tissue FTC concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. | Number of participants who provided a viable sample. | Posted | Median | Inter-Quartile Range | fmol/mg tissue | Post-Intervention (Day 8) |
|
|
|
| Secondary | Median Rectal Tissue Tenofovir (TDF) Concentration | Median rectal tissue TDF concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. | Number of participants who provided a viable sample. | Posted | Median | Inter-Quartile Range | fmol/mg tissue | Post-Intervention (Day 8) |
|
|
|
| Secondary | Median Rectal Tissue Deoxyadenosine Triphosphate (dATP) Concentration | Median rectal tissue dATP concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. | Number of participants who provided a viable sample. | Posted | Median | Inter-Quartile Range | fmol/mg tissue | Baseline, Post-Intervention (Day 8) |
|
|
|
| Secondary | Median Rectal Tissue Deoxycytidine Triphosphate (dCTP) Concentration | Median rectal tissue dCTP concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. | Number of participants who provided a viable sample. | Posted | Median | Inter-Quartile Range | fmol/mg tissue | Baseline, Post-Intervention (Day 8) |
|
|
|
| Secondary | Median Peripheral Blood Mononuclear Cell (PBMC) Deoxyadenosine Triphosphate (dATP) Concentration | Median blood dATP concentrations as measured in fmol/million cells prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. | Number of participants who provided a viable sample. | Posted | Median | Inter-Quartile Range | fmol/million cells | Baseline, Post-Intervention (Day 8) |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 4 |
| 20 |
| EG001 | Truvada | Subjects took one Truvada tablet orally for seven consecutive days. Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally. | 0 | 19 | 0 | 19 | 2 | 19 |
| EG002 | Rectal Gel Lubricant + Truvada | Subjects inserted 5 mL of lubricant in rectum and took one Truvada tablet orally for seven consecutive days Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally. Gel lubricant: Five ml of an over the counter sexual lubricant will be dispensed using an applicator. | 0 | 21 | 0 | 21 | 3 | 21 |
| Gastroenteritis | Infections and infestations | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| 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 |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
|