HIV Infections, Trichomonas Infections
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGMetronidazole
2 gm single dose versus 7 day 500 mg BID dose
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Tulane University Health Sciences Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female * 18 years or older * HIV-positive * TV positive by either wet preparation or culture * ability to refrain from all alcohol use for 24 hours before and after taking oral metronidazole * willing to take metronidazole treatment
Exclusion criteria
* pregnant * incarcerated * previously enrolled * currently taking disulfiram * alcoholism or known liver damage * medical contraindications to metronidazole * treated with metronidazole within the previous 14 days * requires treatment for B.V. per Amsel's criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TV Culture Positive Result | test-of-cure visit at 6-12 days post-treatment completion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TV Culture Positive Result | 3 months post-enrollment | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 7 Day Dose Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose | 135 |
| Single Dose Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose | 135 |
| Total | 270 |
Baseline characteristics
| Characteristic | Single Dose | 7 Day Dose | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 134 Participants | 135 Participants | 269 Participants |
| Age, Continuous | 40.7 years STANDARD_DEVIATION 9.4 | 39.5 years STANDARD_DEVIATION 9.3 | 40.1 years STANDARD_DEVIATION 9.4 |
| Gender Female | 135 Participants | 135 Participants | 270 Participants |
| Gender Male | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 135 participants | 135 participants | 270 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 135 | 0 / 135 |
| serious Total, serious adverse events | 0 / 135 | 0 / 135 |
Outcome results
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.
Time frame: test-of-cure visit at 6-12 days post-treatment completion
Population: Participants who returned for their test of cure visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 7 Day Dose | TV Culture Positive Result | 11 participants |
| Single Dose | TV Culture Positive Result | 21 participants |
Comparison: It was initially estimated that a total of 380 participants (190 per arm) would be required, with 90% power and a significance level of 5%, to establish equivalency between the two treatment arms.31 Enrollment rates were lower than estimated and only 270 participants (135 per arm) were enrolled.p-value: 0.04595% CI: [0.25, 1]Relative risk
p-value: <0.0595% CI: [0.21, 0.98]Chi-squared
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.
Time frame: 3 months post-enrollment
Population: Participants who returned for their 3 mo follow up visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 7 Day Dose | TV Culture Positive Result | 8 participants |
| Single Dose | TV Culture Positive Result | 19 participants |
Comparison: It was initially estimated that a total of 380 participants (190 per arm) would be required, with 90% power and a significance level of 5%, to establish equivalency between the two treatment arms.31 Enrollment rates were lower than estimated and only 270 participants (135 per arm) were enrolled.p-value: =0.0395% CI: [0.21, 0.98]Relative risk