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

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ClinicalTrials.gov Identifier: NCT00808405
Recruitment Status : Completed
First Posted : December 15, 2008
Results First Posted : May 18, 2012
Last Update Posted : December 11, 2013
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Connie Celum, University of Washington

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Genital Herpes
Interventions Drug: acyclovir
Drug: matching placebo
Enrollment 88

Recruitment Details 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  
Arm/Group Title Acyclovir Placebo
Hide Arm/Group Description Acyclovir 400 mg orally three times daily Matching placebo tablet
Period Title: Overall Study
Started 61 27
Completed 61 27
Not Completed 0 0
Arm/Group Title Acyclovir Placebo Total
Hide Arm/Group Description Acyclovir 400 mg orally three times daily Matching placebo tablet Total of all reporting groups
Overall Number of Baseline Participants 61 27 88
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 27 participants 88 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
61
 100.0%
27
 100.0%
88
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 61 participants 27 participants 88 participants
38.66  (10.28) 38.15  (10.31) 38.5  (10.23)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 27 participants 88 participants
Female
61
 100.0%
27
 100.0%
88
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 61 participants 27 participants 88 participants
Zambia 31 13 44
South Africa 30 14 44
1.Primary Outcome
Title Time to Healing of Genital Lesions
Hide Description To examine time to healing of genital lesions among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo
Time Frame Days 1-5, 7, 9, 11, 13
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible women were 18-50 years of age, HIV-1 seronegative, HSV-2 seropositive and who presented to the study clinic with a new genital ulcer. Intention to treat analysis was used.
Arm/Group Title Acyclovir Placebo
Hide Arm/Group Description:
Acyclovir 400 mg orally three times daily
Matching placebo tablet
Overall Number of Participants Analyzed 61 27
Mean (Standard Error)
Unit of Measure: Days
5.1  (0.3) 6.0  (0.6)
2.Secondary Outcome
Title Time to First Negative Herpes Simplex Virus (HSV) DNA PCR
Hide Description To examine the time to first negative HSV DNA PCR among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo
Time Frame Days 1-5, 7, 9, 11, 13
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible women were 18-50 years of age, HIV-1 seronegative, HSV-2 seropositive and who presented to the study clinic with a new genital ulcer. Intention to treat analysis was used.
Arm/Group Title Acyclovir Placebo
Hide Arm/Group Description:
Acyclovir 400 mg orally three times daily
Matching placebo tablet
Overall Number of Participants Analyzed 61 27
Mean (Standard Error)
Unit of Measure: Days
3.0  (0.3) 5.0  (0.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acyclovir Placebo
Hide Arm/Group Description Acyclovir 400 mg orally three times daily Matching placebo tablet
All-Cause Mortality
Acyclovir Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Acyclovir Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/61 (0.00%)   0/27 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Acyclovir Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/61 (0.00%)   0/27 (0.00%) 
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
EMail: ccelum@uw.edu
Responsible Party: Connie Celum, University of Washington
ClinicalTrials.gov Identifier: NCT00808405     History of Changes
Other Study ID Numbers: 34708-A
U01AI052054 ( U.S. NIH Grant/Contract )
First Submitted: November 25, 2008
First Posted: December 15, 2008
Results First Submitted: April 20, 2012
Results First Posted: May 18, 2012
Last Update Posted: December 11, 2013