- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00799058
A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States
A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE I/II TRIAL TO EVALUATE THE SAFETY OF DAPIVIRINE GEL 4759, 0.05% 2.5g AND DAPIVIRINE GEL 4789, 0.05% 2.5g FORMULATIONS AS COMPARED TO THE VAGINAL HEC-BASED UNIVERSAL PLACEBO GEL, 2.5g IN HEALTHY HIV-NEGATIVE WOMEN
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
- Phase 1
Kontakte und Standorte
Studienorte
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Alabama
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Birmingham, Alabama, Vereinigte Staaten, 35294
- University of Alabama at Birmingham, Alabama Microbicide Clinical Research Site (AMCRS)
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California
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Torrance, California, Vereinigte Staaten, 90502
- Harbor-UCLA Medical Center
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60612
- University of Illinois at Chicago
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Maryland
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Baltimore, Maryland, Vereinigte Staaten, 21201
- SNBL Clinical Pharmacology Center
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New York
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New York, New York, Vereinigte Staaten, 10461
- Albert Einstein College of Medicine
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Women 18 to 40 years of age inclusive who can give written informed consent
- Available for all visits and consent to follow all procedures scheduled for the trial
- Healthy and self-reported sexually active
- HIV-negative as determined by an HIV test at time of enrollment
- Willing to be on a stable form of contraception
- In the absence of the use of exogenous hormone(s), have a self-reported regular menstrual cycle
- Upon pelvic/speculum examination and colposcopy at the enrollment visit, the cervix and vagina appear normal as determined by qualified research center staff
- Asymptomatic for genital infections at the time of enrollment
- Willing to refrain from use of vaginal products or objects for 14 days prior to enrollment and for the duration of the trial.
- Documentation of no abnormality on Pap smear within 90 days prior to randomization;
- Willing to answer acceptability and adherence questionnaires throughout the trial
- Willing to refrain from participation in any other research trial for the duration of this trial
- Willing to provide adequate locator information for trial retention purposes and be reachable per local standard procedures
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
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:
- Currently pregnant or having had their last pregnancy outcome within 3 months prior to screening
- Currently breast-feeding, or having breastfed within 3 months prior to screening
- Receipt of any investigational agent within 60 days prior to screening
- Previously participated in any HIV vaccine trial
- Untreated urogenital infections within 2 weeks prior to enrollment
- Presence of any abnormal physical finding on the vulva, vaginal walls or cervix during pelvic/speculum examination and/or colposcopy
- History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, or urethral obstruction
- Pap smear result at screening that requires cryotherapy, biopsy or treatment (other than for infection)
- History of symptomatic or asymptomatic HSV-2
- Any Grade 2, 3 or 4 hematology, chemistry or urinalysis laboratory abnormality at baseline
- Unexplained, undiagnosed abnormal bleeding per vagina during or following vaginal intercourse; or urogenital surgery within 90 days prior to enrollment
- Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex
- Any serious acute, chronic or progressive disease
- Any condition(s) that, in the opinion of the Investigator, might interfere with adherence to trial requirements or evaluation of the trial objectives
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Aktiver Komparator: dapivirine gel 4789
will be applied by participants once daily for 12-weeks treatment period
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dapivirine gel 4789, 0.05%, 2.5g applied once daily
Andere Namen:
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Aktiver Komparator: dapivirine gel 4759
Will be applied by participants once daily for12-weeks treatment period
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dapivirine gel 4759, 0.05%, 2.5g applied once daily
Andere Namen:
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Placebo-Komparator: HEC-based placebo gel, 2.5g containing no Dapivirine
Will be applied once daily for 12-weeks treatment period
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HEC-based universal placebo gel, 2.5g applied once daily
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
The Percentage of Women With the Composite Endpoint of Abnormal Safety Findings.
Zeitfenster: 12 weeks
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A composite endpoint was defined as the percentage of participants with any post-baseline abnormal finding from pelvic/speculum examination, colposcopy finding, STI diagnoses, laboratory test of DAIDS grade 3 or higher and any product-related AE. DAIDS severity grades are defined as follows: Grade 1 = mild Grade 2 = moderate Grade 3 = severe Grade 4 = potentially life-threatening Grade 5 = death |
12 weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Changes in the Vaginal Flora
Zeitfenster: 16 weeks
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Cervicovaginal fluid specimens will be obtained to determine vaginal flora before first gel application and at Visits 3, 5, and 6. Appropriate statistical analyses incorporating repeated measures will be used to assess the changes in the vaginal flora in women using Dapivirine Gel 4759, 0.05% 2.5g, Dapivirine Gel 4789, 0.05% 2.5g or the vaginal HEC-based universal placebo gel, 2.5g. Nugent scores were used to assess changes in vaginal flora, and were categorized into three levels: (1) negative for BV (score: 0-3); (2) altered vaginal flora (score: 4-6); and (3) BV (score: 7-10). |
16 weeks
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The Distribution of Dapivirine Levels Observed in Plasma Samples at Each Specified Time Point
Zeitfenster: 12 weeks
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Dapivirine levels observed in plasma will be summarized using simple descriptive statistics.
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12 weeks
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The Adherence to Once Daily Application of a Vaginal Microbicide Gel Over a 12-week Period in Healthy, Sexually Active, HIV-negative Women
Zeitfenster: 12 weeks
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Adherence is defined as the percentage of participants who used the gel each day of the preceding 14 days, based on participant self reports.
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12 weeks
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Changes in the Vaginal pH
Zeitfenster: 12 weeks
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Cervicovaginal fluid specimens will be obtained to determine vaginal pH before first gel application and at screening, enrolment and visit 5 (week 12).
Appropriate statistical analyses incorporating repeated measures will be used to assess the changes in the vaginal pH in women using Dapivirine Gel 4759, 0.05% 2.5g, Dapivirine Gel 4789, 0.05% 2.5g or the vaginal HEC-based universal placebo gel, 2.5g.
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12 weeks
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The Distribution of Dapivirine Levels Observed in Vaginal Fluid at Each Specified Time Point.
Zeitfenster: 12 weeks. Measured at 2, 4, and 8 weeks post-enrolment and at one of these at week 12; 24, 48, or 72 hours after gel discontinuation. (Participants were randomized to have vaginal fluid samples collected at one of these visits (5a, 5b, or 5c).
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The distribution of dapivirine levels observed in each type of sample will be summarized using simple descriptive statistics.
In addition, the proportion of women with detectable dapivirine concentrations will be calculated for each type of sample at each collection time point.
Exploratory analyses of dapivirine concentration data will also be performed to take into account information reported in a diary regarding menses and tampon use throughout the trial.
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12 weeks. Measured at 2, 4, and 8 weeks post-enrolment and at one of these at week 12; 24, 48, or 72 hours after gel discontinuation. (Participants were randomized to have vaginal fluid samples collected at one of these visits (5a, 5b, or 5c).
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The Distribution of Dapivirine Levels Observed in Vaginal Tissue at Each Specified Time Point.
Zeitfenster: 12 weeks. Measured at 2, 4, and 8 weeks post-enrolment and at one of these at week 12; 24, 48, or 72 hours after gel discontinuation. (Participants were randomized to have vaginal fluid samples collected at one of these visits (5a, 5b, or 5c).
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The distribution of dapivirine levels observed in vaginal tissue sample will be summarized using simple descriptive statistics.
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12 weeks. Measured at 2, 4, and 8 weeks post-enrolment and at one of these at week 12; 24, 48, or 72 hours after gel discontinuation. (Participants were randomized to have vaginal fluid samples collected at one of these visits (5a, 5b, or 5c).
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Acceptability of Once Daily Application of a Vaginal Microbicide Gel Over a 12-week Period in Healthy, Sexually Active, HIV-negative Women
Zeitfenster: 12 weeks
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Acceptability was assessed as the percentage of participants at week 12 who were willing to use the gel every day if proven to prevent HIV.
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12 weeks
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Mitarbeiter und Ermittler
Ermittler
- Studienstuhl: Dr Annalene Nel, International Partnership for Microbicides
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IPM 020
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
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