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Trial record 7 of 33 for:    " November 12, 2008":" December 12, 2008"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Effect of Valacyclovir in the Reduction of HSV-2 Recurrence and Shedding

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ClinicalTrials.gov Identifier: NCT00803543
Recruitment Status : Completed
First Posted : December 5, 2008
Results First Posted : July 13, 2017
Last Update Posted : July 13, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Nicholas Van Wagoner, MD, University of Alabama at Birmingham

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions HIV
HIV Infections
Interventions Drug: Valacyclovir
Drug: Placebo
Enrollment 103
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Valacyclovir Placebo
Hide Arm/Group Description Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks Placebo: Dosage: Two tablets once a day for 24 weeks
Period Title: Overall Study
Started 69 34
Completed 45 22
Not Completed 24 12
Arm/Group Title Valacyclovir Placebo Total
Hide Arm/Group Description Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks Placebo: Dosage: Two tablets once a day for 24 weeks Total of all reporting groups
Overall Number of Baseline Participants 45 22 67
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 45 participants 22 participants 67 participants
45
(23 to 68)
43
(27 to 61)
45
(23 to 68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 22 participants 67 participants
Female
8
  17.8%
1
   4.5%
9
  13.4%
Male
37
  82.2%
21
  95.5%
58
  86.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 22 participants 67 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
45
 100.0%
22
 100.0%
67
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 22 participants 67 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
25
  55.6%
9
  40.9%
34
  50.7%
White
20
  44.4%
13
  59.1%
33
  49.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants 22 participants 67 participants
45 22 67
Absolute CD4 (cluster of differentiation 4) Count  
Mean (Full Range)
Unit of measure:  Cell/ml
Number Analyzed 45 participants 22 participants 67 participants
528
(165 to 1135)
693
(198 to 1272)
582
(165 to 1272)
Number with Undetectable Viral Load  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants 22 participants 67 participants
40 19 59
1.Primary Outcome
Title Herpes Simplex Virus Type 2 Recurrence
Hide Description Number of recurrences of genital herpes
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No participants reported genital herpes recurrence during the study.
Arm/Group Title Valacyclovir Placebo
Hide Arm/Group Description:
Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
Placebo: Dosage: Two tablets once a day for 24 weeks
Overall Number of Participants Analyzed 45 22
Measure Type: Number
Unit of Measure: Recurrence
0 0
2.Primary Outcome
Title CD4 Count
Hide Description CD4 count as measured after 24 weeks of placebo versus valacyclovir. Reports as cells/ml
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Valacyclovir Placebo
Hide Arm/Group Description:
Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
Placebo: Dosage: Two tablets once a day for 24 weeks
Overall Number of Participants Analyzed 45 22
Mean (Full Range)
Unit of Measure: cells/ml
536
(191 to 1112)
627.5
(199 to 1268)
3.Primary Outcome
Title Number of Participants With an HIV Viral Load of <500 Copies/ml
Hide Description Number of participants with an HIV Viral Load of <500 copies/ml at 24 weeks
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Valacyclovir Placebo
Hide Arm/Group Description:
Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
Placebo: Dosage: Two tablets once a day for 24 weeks
Overall Number of Participants Analyzed 45 22
Measure Type: Number
Unit of Measure: Participants
38 20
4.Primary Outcome
Title Rate of Asymptomatic HSV-2 Genital Shedding
Hide Description Proportion of days on which HSV shedding was observed. This part of the study was performed in a subset of participants (N = 34). Participant collected daily genital specimens for 8 weeks starting at week 16 and continuing through week 24 of the study.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Valacyclovir Placebo
Hide Arm/Group Description:
Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
Placebo: Dosage: Two tablets once a day for 24 weeks
Overall Number of Participants Analyzed 26 8
Overall Number of Units Analyzed
Type of Units Analyzed: Total Number of Days Assessed
1456 448
Measure Type: Number
Unit of Measure: Proportion of days
0.0009 0.0001
Time Frame Entire study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Valacyclovir Placebo
Hide Arm/Group Description Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks Placebo: Dosage: Two tablets once a day for 24 weeks
All-Cause Mortality
Valacyclovir Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/22 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Valacyclovir Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/22 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Valacyclovir Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/22 (0.00%) 
Small populations size. High level of patient withdrawal and loss to follow up.
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: Nicholas Van Wagoner
Organization: University of Alabama at Birmingham
Phone: 205-934-2840
EMail: nvw@uab.edu
Responsible Party: Nicholas Van Wagoner, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00803543     History of Changes
Other Study ID Numbers: F080718009
First Submitted: December 3, 2008
First Posted: December 5, 2008
Results First Submitted: July 11, 2015
Results First Posted: July 13, 2017
Last Update Posted: July 13, 2017