GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women (PK/GUD)

This study has been completed.
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Connie Celum, University of Washington Identifier:
First received: November 25, 2008
Last updated: November 15, 2013
Last verified: November 2013
Results First Received: April 20, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Genital Herpes
Interventions: Drug: acyclovir
Drug: matching placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between January and December 2009, women from Johannesburg, South Africa and Lusaka, Zambia who had previously participated in the HPTN 039 (NCT00076232) study, as well as other women in the community who presented to the research clinics with genetic ulcer disease (GUD) during the recruitment period, were invited to participate in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Acyclovir Acyclovir 400 mg orally three times daily
Placebo Matching placebo tablet

Participant Flow:   Overall Study
    Acyclovir     Placebo  
STARTED     61     27  
COMPLETED     61     27  
NOT COMPLETED     0     0  

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Acyclovir Acyclovir 400 mg orally three times daily
Placebo Matching placebo tablet
Total Total of all reporting groups

Baseline Measures
    Acyclovir     Placebo     Total  
Number of Participants  
[units: participants]
  61     27     88  
[units: participants]
<=18 years     0     0     0  
Between 18 and 65 years     61     27     88  
>=65 years     0     0     0  
[units: years]
Mean (Standard Deviation)
  38.66  (10.28)     38.15  (10.31)     38.5  (10.23)  
[units: participants]
Female     61     27     88  
Male     0     0     0  
Region of Enrollment  
[units: participants]
Zambia     31     13     44  
South Africa     30     14     44  

  Outcome Measures
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1.  Primary:   Time to Healing of Genital Lesions   [ Time Frame: Days 1-5, 7, 9, 11, 13 ]

2.  Secondary:   Time to First Negative Herpes Simplex Virus (HSV) DNA PCR   [ Time Frame: Days 1-5, 7, 9, 11, 13 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Connie Celum, MD, MPH
Organization: University of Washington
phone: 206-520-3824

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Connie Celum, University of Washington Identifier: NCT00808405     History of Changes
Other Study ID Numbers: 34708-A
UO1 AI52054
Study First Received: November 25, 2008
Results First Received: April 20, 2012
Last Updated: November 15, 2013
Health Authority: South Africa: Human Research Ethics Committee
United States: Institutional Review Board
Zambia: Research Ethics Committee