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View Clinical Trial (Medical Research Study)
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A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States - NCT00799058-21201 (Clinical Trial 255793)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy255793.aspx
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| City: |
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Baltimore |
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State:
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MD |
| Zip Code: |
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21201 |
| Conditions: |
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HIV-1 Infections |
| Purpose: |
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IPM 020 is a double-blind, randomized, placebo-controlled Phase I/II expanded safety trial
being conducted at 5 research centers in the United States among approximately 180 healthy,
sexually active, HIV-negative women to assess the safety of Dapivirine Gel 4759, 0.05% 2.5g
and Dapivirine Gel 4789, 0.05% 2.5g as compared to the HEC-based universal placebo.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
1. Women 18 to 40 years of age inclusive who can give written informed consent
2. Available for all visits and consent to follow all procedures scheduled for the trial
3. Healthy and self-reported sexually active
4. HIV-negative as determined by an HIV test at time of enrollment
5. Willing to be on a stable form of contraception
6. In the absence of the use of exogenous hormone(s), have a self-reported regular
menstrual cycle
7. Upon pelvic/speculum examination and colposcopy at the enrollment visit, the cervix
and vagina appear normal as determined by qualified research center staff
8. Asymptomatic for genital infections at the time of enrollment
9. Willing to refrain from use of vaginal products or objects for 14 days prior to
enrollment and for the duration of the trial.
10. Documentation of no abnormality on Pap smear within 90 days prior to randomization;
11. Willing to answer acceptability and adherence questionnaires throughout the trial
12. Willing to refrain from participation in any other research trial for the duration of
this trial
13. Willing to provide adequate locator information for trial retention purposes and be
reachable per local standard procedures
14. Willing to abstain from all the following criteria beginning 48 hours prior to each
trial visit:
- Vaginal intercourse
- Oral contact with her genitalia
- Internal vaginal washing
- Penetration of the vagina by fingers, sex toys, or any other objects, including
medications
15. Willing to abstain from all of the following for 3 days after biopsy procedures:
- Vaginal intercourse
- Oral contact with her genitalia
- Internal vaginal washing
- Penetration of the vagina by fingers, sex toys, or any other objects, including
medications
Exclusion Criteria:
1. Currently pregnant or having had their last pregnancy outcome within 3 months prior
to screening
2. Currently breast-feeding, or having breastfed within 3 months prior to screening
3. Receipt of any investigational agent within 60 days prior to screening
4. Previously participated in any HIV vaccine trial
5. Untreated urogenital infections within 2 weeks prior to enrollment
6. Presence of any abnormal physical finding on the vulva, vaginal walls or cervix
during pelvic/speculum examination and/or colposcopy
7. History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding,
or urethral obstruction
8. Pap smear result at screening that requires cryotherapy, biopsy or treatment (other
than for infection)
9. History of symptomatic or asymptomatic HSV-2
10. Any Grade 2, 3 or 4 hematology, chemistry or urinalysis laboratory abnormality at
baseline
11. Unexplained, undiagnosed abnormal bleeding per vagina during or following vaginal
intercourse; or urogenital surgery within 90 days prior to enrollment
12. Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of
sensitivity/allergy to latex
13. Any serious acute, chronic or progressive disease
14. Any condition(s) that, in the opinion of the Investigator, might interfere with
adherence to trial requirements or evaluation of the trial objectives |
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| Study is available at: |
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SNBL Clinical Pharmacology Center
Baltimore, MD 21201
United States
Primary Contact:
Katrina Crawford
Email: kcrawford@snbl-cpc.com
Phone: 410-706-8835 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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