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| ID | Type | Description | Link |
|---|---|---|---|
| U19AI061972 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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The purpose of this study is to determine if the 2 gram single dose of metronidazole is as effective as the 7 day 500 mg BID dose for treatment of Trichomonas vaginalis (TV) among HIV-infected women.
This is a Phase IV equivalency trial as both doses of metronidazole are listed in the the Centers for Disease Control and Prevention Treatment Guidelines for the treatment of T vaginalis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose | Active Comparator | Metronidazole 2 gm single dose |
|
| 7 day dose | Active Comparator | Metronidazole 500 mg dose x 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metronidazole | Drug | 2 gm single dose versus 7 day 500 mg BID dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| TV Culture Positive Result | At the participants' test of cure (TOC) visits they were screened for Trichomonas vaginalis using (InPouch) culture. Presence of parasite will yield a culture positive result. | test-of-cure visit at 6-12 days post-treatment completion |
| Measure | Description | Time Frame |
|---|---|---|
| TV Culture Positive Result | Participants who returned for their follow up visits were tested for Trichomonas vaginalis using InPouch culture. If parasites are present, it will yield a culture positive result. | 3 months post-enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Kissinger, Ph.D. | Tulane University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HIV Outpatient Clinic | New Orleans | Louisiana | 70112 | United States | ||
| NOAIDS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30297322 | Derived | Kissinger P, Muzny CA, Mena LA, Lillis RA, Schwebke JR, Beauchamps L, Taylor SN, Schmidt N, Myers L, Augostini P, Secor WE, Bradic M, Carlton JM, Martin DH. Single-dose versus 7-day-dose metronidazole for the treatment of trichomoniasis in women: an open-label, randomised controlled trial. Lancet Infect Dis. 2018 Nov;18(11):1251-1259. doi: 10.1016/S1473-3099(18)30423-7. Epub 2018 Oct 5. | |
| 21423852 | Derived | Kissinger P, Mena L, Levison J, Clark RA, Gatski M, Henderson H, Schmidt N, Rosenthal SL, Myers L, Martin DH. A randomized treatment trial: single versus 7-day dose of metronidazole for the treatment of Trichomonas vaginalis among HIV-infected women. J Acquir Immune Defic Syndr. 2010 Dec 15;55(5):565-71. doi: 10.1097/QAI.0b013e3181eda955. |
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HIV-infected women undergoing a routine gynecological examination performed by a clinic health care provider between May 1, 2006 and July 17, 2009 were tested for Trichomonas Vaginalis (TV) by culture as standard of care practice in selected public HIV outpatient clinics in New Orleans, Louisiana; Houston, Texas; and Jackson, Mississippi.
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| ID | Title | Description |
|---|---|---|
| FG000 | 7 Day Dose | Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose |
| FG001 | Single Dose | Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 7 Day Dose | Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose |
| BG001 | Single Dose | Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose |
| 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 | TV Culture Positive Result | At the participants' test of cure (TOC) visits they were screened for Trichomonas vaginalis using (InPouch) culture. Presence of parasite will yield a culture positive result. | Participants who returned for their test of cure visit | Posted | Number | participants | test-of-cure visit at 6-12 days post-treatment completion |
|
4 years and 2 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 | 7 Day Dose | Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose |
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Generalizability is always a concern in clinical trials, however our findings are likely generalizable to the majority of HIV-infected women in the U.S. though studies in Caucasian and Hispanic women are needed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patricia Kissinger, PhD | Tulane University | 5049887320 | kissing@tulane.edu |
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| ID | Term |
|---|---|
| D014245 | Trichomonas Infections |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000086982 | Blood-Borne Infections |
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| ID | Term |
|---|---|
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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| New Orleans |
| Louisiana |
| 70119 |
| United States |
| Crossroads Clinic | Jackson | Mississippi | 39216 | United States |
| Thomas St Clinic | Houston | Texas | 77009 | United States |
| Northwest Clinic | Houston | Texas | 77040 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | TV Culture Positive Result | Participants who returned for their follow up visits were tested for Trichomonas vaginalis using InPouch culture. If parasites are present, it will yield a culture positive result. | Participants who returned for their 3 mo follow up visit | Posted | Number | participants | 3 months post-enrollment |
|
|
|
|
| 0 |
| 135 |
| 0 |
| 135 |
| EG001 | Single Dose | Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose | 0 | 135 | 0 | 135 |
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| D003141 |
| Communicable Diseases |
| 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 |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Continuous variables were assessed for normality, and tested accordingly. When appropriate, continuous variables were categorized using clinically relevant cut-points. Categorical variables were compared using the Chi-square test. The measure of association at 3 months was calculated as a relative risk with 95% confidence interval.