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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Nicholas Van Wagoner, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00803543
First received: December 3, 2008
Last updated: June 14, 2017
Last verified: June 2017
Results First Received: July 11, 2015  
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

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Valacyclovir Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
Placebo Placebo: Dosage: Two tablets once a day for 24 weeks

Participant Flow:   Overall Study
    Valacyclovir   Placebo
STARTED   69   34 
COMPLETED   45   22 
NOT COMPLETED   24   12 



  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.
No text entered.

Reporting Groups
  Description
Valacyclovir Valacyclovir: 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks
Placebo Placebo: Dosage: Two tablets once a day for 24 weeks
Total Total of all reporting groups

Baseline Measures
   Valacyclovir   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 45   22   67 
Age 
[Units: Years]
Mean (Full Range)
 45 
 (23 to 68) 
 43 
 (27 to 61) 
 45 
 (23 to 68) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      8  17.8%      1   4.5%      9  13.4% 
Male      37  82.2%      21  95.5%      58  86.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
     
United States   45   22   67 
Absolute CD4 (cluster of differentiation 4) Count 
[Units: Cell/ml]
Mean (Full Range)
 528 
 (165 to 1135) 
 693 
 (198 to 1272) 
 582 
 (165 to 1272) 
Number with Undetectable Viral Load 
[Units: Participants]
 40   19   59 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Herpes Simplex Virus Type 2 Recurrence   [ Time Frame: 24 Weeks ]

2.  Primary:   CD4 Count   [ Time Frame: 24 weeks ]

3.  Primary:   Number of Participants With an HIV Viral Load of <500 Copies/ml   [ Time Frame: 24 weeks ]

4.  Primary:   Rate of Asymptomatic HSV-2 Genital Shedding   [ Time Frame: 24 weeks ]


  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
Small populations size. High level of patient withdrawal and loss to follow up.


  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: Nicholas Van Wagoner
Organization: University of Alabama at Birmingham
phone: 205-934-2840
e-mail: 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
Study First Received: December 3, 2008
Results First Received: July 11, 2015
Last Updated: June 14, 2017