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Clinical Trials/PACTR2010060002133418
PACTR2010060002133418
Not yet recruiting
未知

A study to determine the feasibility of conducting a microbicide trial of daily vaginal gel and to inform the way adherence should be assessed

Medical Research Council0 sites225 target enrollmentMay 26, 2010
ConditionsHIV/AIDS

Overview

Phase
未知
Intervention
Not specified
Conditions
HIV/AIDS
Sponsor
Medical Research Council
Enrollment
225
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 26, 2010
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 years and above at enrolment
  • Likely to be sexually active at entry and during follow\-up
  • Willing to use study gel as instructed
  • Willing to return applicators every week day
  • Willing to attend the clinic every 4 weeks and be interviewed
  • Willing to be followed up and interviewed if she defaults
  • Willing to receive health education about condoms
  • Willing to undergo pregnancy tests on a monthly basis
  • Willing and able to give informed consent

Exclusion Criteria

  • Using a product in a trial, or otherwise e.g. licensed spermicide, that is likely to impact on the outcome of this study and she is unwilling to stop use for the duration of study
  • Unable to agree a reliable method of contact with the field team
  • Likely to move out of the area within the next 3 months
  • Pregnant (including positive pregnancy test at enrolment)
  • Has clinical condition considered by the study management group to make enrolment inadvisable
  • Considered by the study personnel to be unlikely to be able to comply with the study procedures
  • Previously enrolled on MDP301 trial

Outcomes

Primary Outcomes

Not specified

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