Valacyclovir vs. Acyclovir as HSV-2 Suppressive Therapy: Effect on Plasma HIV-1 Levels Among HIV-1/HSV-2 Co-infected Persons (ACV-VAL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Connie Celum, University of Washington
ClinicalTrials.gov Identifier:
NCT01026454
First received: December 2, 2009
Last updated: March 10, 2014
Last verified: March 2014
Results First Received: November 15, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HSV Infection
HIV Infection
Interventions: Drug: acyclovir
Drug: valacyclovir

  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
HSV-2/HIV-1 dually-infected participants were recruited between March and November 2010 from Thika, Kenya.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
66 participants screened; 34 excluded (33 did not meet inclusion criteria, 1 declined study participation); 32 enrolled

Reporting Groups
  Description
Acyclovir Then Valacyclovir Acyclovir 400 mg orally twice daily (12 weeks), Washout (2 weeks), Valacyclovir 1.5 g orally twice daily (12 weeks)
Valacyclovir Then Acyclovir Valacyclovir 1.5 g orally twice daily (12 weeks), Washout (2 weeks), Acyclovir 400 mg orally twice daily (12 weeks)

Participant Flow for 3 periods

Period 1:   First Intervention
    Acyclovir Then Valacyclovir     Valacyclovir Then Acyclovir  
STARTED     18     14  
COMPLETED     18     14  
NOT COMPLETED     0     0  

Period 2:   Washout
    Acyclovir Then Valacyclovir     Valacyclovir Then Acyclovir  
STARTED     18     14  
COMPLETED     18     14  
NOT COMPLETED     0     0  

Period 3:   Second Intervention
    Acyclovir Then Valacyclovir     Valacyclovir Then Acyclovir  
STARTED     17     14  
COMPLETED     16     13  
NOT COMPLETED     1     1  
Pregnancy                 1                 1  



  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
Acyclovir Then Valacyclovir acyclovir 400 mg orally twice daily for 12 weeks, 2 week washout, then valacyclovir 1.5 g orally twice daily for 12 weeks
Valacyclovir Then Acyclovir valacyclovir 1.5 g orally twice daily for 12 weeks, 2 week washout, then acyclovir 400 mg orally twice daily for 12 weeks
Total Total of all reporting groups

Baseline Measures
    Acyclovir Then Valacyclovir     Valacyclovir Then Acyclovir     Total  
Number of Participants  
[units: participants]
  18     14     32  
Age, Customized  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     18     14     32  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     11     7     18  
Male     7     7     14  
Region of Enrollment  
[units: participants]
     
Kenya     18     14     32  
Plasma HIV-1 RNA Level at Enrollment  
[units: log10┬ácopies/mL]
Mean ± Standard Deviation
  4.05  ± 0.72     4.08  ± 0.85     4.07  ± 0.75  



  Outcome Measures

1.  Primary:   Mean Level of HIV-1 RNA in Plasma of Participants While on Acyclovir or Valacyclovir.   [ Time Frame: Weekly for 12 weeks per intervention ]

2.  Secondary:   Safety of Valacyclovir 1.5 Gram Orally Twice Daily in HIV-1 Seropositive Persons.   [ Time Frame: 28 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  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: 206-520-3800
e-mail: ccelum@uw.edu


Publications:
Publications automatically indexed to this study:

Responsible Party: Connie Celum, University of Washington
ClinicalTrials.gov Identifier: NCT01026454     History of Changes
Other Study ID Numbers: 37162-A
Study First Received: December 2, 2009
Results First Received: November 15, 2013
Last Updated: March 10, 2014
Health Authority: United States: Institutional Review Board