Trial record 7 of 46 for:    " May 26, 2010":" June 25, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Safety and Pharmacokinetic Trial in Healthy HIV-Negative Women to Assess the Delivery of Dapivirine From a Vaginal Ring

This study has been completed.
Sponsor:
Information provided by:
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:
NCT01144013
First received: June 10, 2010
Last updated: June 14, 2010
Last verified: June 2010
  Purpose

The proposed study is a single center, double-blind placebo-controlled trial to assess the safety and tolerability of the dapivirine ring as compared to a placebo ring when inserted for 28 days in 16 healthy, HIV-negative women.


Condition Intervention Phase
HIV Infections
Drug: dapivirine
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Double-Blind, Randomised, Placebo-Controlled Safety and Pharmacokinetic Trial in Healthy HIV-Negative Women to Assess Delivery of Dapivirine From the Matrix Vaginal Ring Containing 25 MG of Dapivirine

Resource links provided by NLM:


Further study details as provided by International Partnership for Microbicides, Inc.:

Primary Outcome Measures:
  • Safety: To assess the safety and tolerability of the dapivirine vaginal ring, the endpoint was the proportion of women on the dapivirine or placebo ring experiencing specific, protocol-defined safety events during the study (see description). [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    • mucosal abnormalities (as defined in the CONRAD/WHO manual) visible during naked eye examination and/or colposcopy
    • positive diagnostic tests for trichomonas, gonorrhea, and/or chlamydia
    • at least one AE during the trial period
    • any laboratory abnormalities on hematology and biochemistry
    • abnormal vaginal pH and/or abnormal vaginal flora during the course of the trial.

  • Pharmacokinetics: assessed by measurement of the concentrations of dapivirine in plasma and in vaginal fluids (collected by Tear Test Strips) before, during and after the trial period. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: August 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dapivirine Vaginal Ring Drug: dapivirine
A platinum-catalysed silicone elastomer matrix vaginal ring containing 25mg of dapivirine used over 28 days
Experimental: Placebo Vaginal Ring Drug: placebo
Placebo vaginal ring containing no dapivirine

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • were females between 18 and 40 years of age, inclusive
  • were willing and able to give written, informed consent
  • were available for all visits and consented to follow all procedures scheduled for the trial
  • were healthy, based on medical history, vital signs, physical examination, urinalysis (dipstick and microscopy), laboratory evaluations for genital infections (gonorrhea, chlamydia and trichomonas), and laboratory evaluations for hematology and biochemistry
  • were HIV-negative, as determined by an HIV test at screening
  • were willing to abstain from sexual activity for the duration of the period of ring use
  • were on a stable form of contraception, defined as a stable oral contraceptive regimen for at least two months prior to enrollment; OR a transdermal contraceptive patch for at least three months prior to enrollment; OR long-acting progestins for at least six months prior to enrollment; OR had an intra-uterine device (IUD) inserted (with no vaginal or gynecological complaints associated with its use) at least three months prior to enrollment; OR had undergone surgical sterilization at least three months prior to enrollment; AND were willing to use oral contraceptives, if necessary, to avoid menstruation while taking part in this trial
  • were asymptomatic for genital infections at the time of enrollment, and the cervix and vagina appeared normal upon pelvic examination and colposcopy, as determined by the investigator
  • were willing to refrain from the use of vaginal products or objects including, but not limited to, tampons, cotton wool, rags, diaphragms, cervical caps (or any other vaginal barrier method), douches, lubricants, vibrators/dildos, non-trial vaginal rings and drying agents for 14 days prior to enrollment and for the duration of the trial
  • were willing to refrain from participation in any other research trial for the duration of this trial
  • were willing to provide adequate locator information for trial retention purposes and were reachable per local standard procedures (e.g. by home visit or telephone, or via family or close neighbor contacts (confidentiality was to be maintained))
  • were hepatitis B and C negative at the time of screening.

Exclusion Criteria:

  • had a history of anaphylaxis or severe allergy resulting in angioedema, or a history of sensitivity/allergy to latex or silicone
  • were pregnant or breast-feeding, or had their last pregnancy outcome within three months prior to screening
  • were participating in any other clinical research trial involving investigational or marketed products at the time of this trial or within two months prior to screening
  • had a history or diagnosis of and/or treatment for a sexually transmitted disease within the previous three months
  • had a history of genital tract surgery within the previous two months
  • had a current diagnosis of sexually transmitted infections (STIs) (gonorrhea, chlamydia and/or trichomonas)
  • had current vulvar or vaginal symptoms/abnormalities that could influence the trial results
  • had a history of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding or urethral obstruction, incontinence or urge incontinence
  • had symptomatic genital herpes simplex virus (HSV) infection or a history of genital herpetic infection
  • had current non-iatrogenic pelvic/colposcopic examination findings involving deep epithelial disruption
  • had any Grade 2, 3 or 4 hematology, biochemistry or urinalysis laboratory abnormality at baseline (screening), according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading Adverse Events
  • had a Pap test result at screening that required cryotherapy, biopsy, treatment (other than for infection) or further evaluation; this included any findings of atypical squamous cells of undetermined significance (ASCUS)
  • had any condition(s) that, in the opinion of the investigator, could interfere with adherence to trial requirements or evaluation of the trial objectives.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01144013

Locations
Belgium
SGS Life Sciences Center
Antwerp, Flanders, Belgium
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
Investigators
Study Director: Annalene Nel, PhD IPM
  More Information

No publications provided

Responsible Party: Annalene Nel, MBChB, PhD / Chief Medical Officer, International Partnership for Microbicides
ClinicalTrials.gov Identifier: NCT01144013     History of Changes
Other Study ID Numbers: IPM 024
Study First Received: June 10, 2010
Last Updated: June 14, 2010
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by International Partnership for Microbicides, Inc.:
HIV Infections
HIV seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 22, 2014