- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00446979
Safety Study of UC-781 Vaginal Microbicide
Phase I Study of the Safety and Acceptability of UC-781 Topical Vaginal Microbicide in Women and Acceptability in Their Male Partners,Chiang Rai, Thailand
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
-
-
-
Chiang Rai, Thailand, 57000
- Chiang Rai Health Club
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria for women:
- Age 18-50 years old
- Regular menses
- HIV-1 seronegative at screening
- Normal Pap smear at screening or documented normal Pap smear within six months prior to screening
- No evidence of reproductive tract infection (RTI)
- Willing and able to comply with study procedures, including pelvic exams, colposcopy, maintaining a study coital and symptom log, and applying assigned study gel per protocol
- Agree to abstain from sexual intercourse for 24 hours prior to the enrollment visit
Agree to abstain from the following activities from at least 48 hours prior to enrollment through the Day 14 visit:
- Insertion of fingers and other objects into the vagina
- Receiving oral sex
- Receiving anal sex
- Using a diaphragm, cervical cap, female condom, or vaginal contraceptive ring
- Using vaginal products other than the study gels, including douches, lubricants, or feminine hygiene products
- In a monogamous sexually active relationship with one male partner
- Report having vaginal intercourse only with that partner at least two times per week
- No other reported partner in the prior six months and no plan to have another partner for the duration of the study
- Agree to use condoms for each act of vaginal intercourse during participation in the study
- Their male partner is informed and also consents to participate in the study
- Willing to have male partner informed and treated if an STD is diagnosed at screening or during the study
Inclusion Criteria for men:
- Age 18 years or older
- HIV-seronegative and free of other STI at screening exam
- One female sexual partner; no other reported partner in the prior six months and no plan to have another partner for the duration of the study
- Willing and able to comply with study procedures, including clinic visits, interviews and acceptability evaluation, and consistent use of condoms during enrollment in the study
- Willing to have female partner informed and treated if an STD is diagnosed at screening or during the study
Exclusion Criteria for women:
- Pregnancy or desire to become pregnant at time of study participation
- Currently breastfeeding
- Delivery or abortion within last eight weeks
History of any male sexual partner other than current partner in past six months
- No abnormal (DAIDS grade 1 or higher) laboratory results at baseline, including hematology, liver and kidney function
- History of post-coital vaginal bleeding in the past three months
- History of surgery to remove uterus or cervix
- History of surgery on the external genitalia, vaginal, or cervix in the past month
- Clinically significant chronic medical condition that is considered progressive, including cardiopulmonary disease, renal disease, hepatic disease, diabetes mellitus.
- History of sensitivity/allergy to latex
- Existence of a clinically detectable genital abnormality at screening (e.g. ulcer, congenital abnormality, any lesion with mucosal disruption)
- Concurrent participation in another trial of a vaginal product
- Have any other condition that in the opinion of the investigator might interfere with the evaluation of the study objectives
Exclusion Criteria for men:
- History of genital surgery in the past month
- Clinical or laboratory evidence of an STI.
- History of sensitivity/allergy to latex
- History of any sexual partner other than their current partner in the past six months
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 1
UC 781 0.1% carbomer gel
|
UC 781 0.1% or UC 781 0.25%, applied vaginally twice daily for two intermenstrual weeks
|
Experimental: 2
UC 781 0.25% carbomer gel
|
UC 781 0.1% or UC 781 0.25%, applied vaginally twice daily for two intermenstrual weeks
|
Placebo-Komparator: 3
Placebo vaginal gel
|
HEC (hydroxyethyl cellulose) Control Gel applied vaginally twice daily for two weeks
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Genital tract inflammation or epithelial disruption as assessed by naked eye and colposcopic inspection according to established guidelines
Zeitfenster: 2 weeks
|
2 weeks
|
Symptoms of irritation
Zeitfenster: two weeks
|
two weeks
|
Changes in vaginal flora
Zeitfenster: Two weeks
|
Two weeks
|
Assessment of pro-inflammatory cytokines in the genital tract
Zeitfenster: Two weeks
|
Two weeks
|
Other product-related adverse events
Zeitfenster: Two weeks
|
Two weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
acceptability of UC-781 gel use
Zeitfenster: Two weeks
|
Two weeks
|
systemic absorption of UC-781
Zeitfenster: Two weeks
|
Two weeks
|
anti-HIV activity of genital secretions in the presence of UC-781 gel
Zeitfenster: Two weeks
|
Two weeks
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Sara J Whitehead, MD, MPH, Centers for Disease Control and Prevention
- Hauptermittler: Chitlada Utaipiboon, MD, Thailand MOPH - U.S. CDC Collaboration
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- RNA-Virusinfektionen
- Viruserkrankungen
- Infektionen
- Durch Blut übertragene Infektionen
- Übertragbare Krankheiten
- Sexuell übertragbare Krankheiten, viral
- Sexuell übertragbare Krankheiten
- Lentivirus-Infektionen
- Retroviridae-Infektionen
- Immunologische Mangelsyndrome
- Erkrankungen des Immunsystems
- HIV-Infektionen
- Antiinfektiva
- Antivirale Mittel
- Antiretrovirale Mittel
- UC-781
Andere Studien-ID-Nummern
- CDC-NCHHSTP-4744
- MOPH 109/2548
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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