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Trial record 24 of 126 for:    HSV-2

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

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ClinicalTrials.gov Identifier: NCT01026454
Recruitment Status : Completed
First Posted : December 4, 2009
Results First Posted : March 5, 2014
Last Update Posted : April 8, 2014
Sponsor:
Information provided by (Responsible Party):
Connie Celum, University of Washington

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HSV Infection
HIV Infection
Interventions Drug: acyclovir
Drug: valacyclovir
Enrollment 32
Recruitment Details HSV-2/HIV-1 dually-infected participants were recruited between March and November 2010 from Thika, Kenya.
Pre-assignment Details 66 participants screened; 34 excluded (33 did not meet inclusion criteria, 1 declined study participation); 32 enrolled
Arm/Group Title Acyclovir Then Valacyclovir Valacyclovir Then Acyclovir
Hide Arm/Group Description Acyclovir 400 mg orally twice daily (12 weeks), Washout (2 weeks), Valacyclovir 1.5 g orally twice daily (12 weeks) Valacyclovir 1.5 g orally twice daily (12 weeks), Washout (2 weeks), Acyclovir 400 mg orally twice daily (12 weeks)
Period Title: First Intervention
Started 18 14
Completed 18 14
Not Completed 0 0
Period Title: Washout
Started 18 14
Completed 18 14
Not Completed 0 0
Period Title: Second Intervention
Started 17 14
Completed 16 13
Not Completed 1 1
Reason Not Completed
Pregnancy             1             1
Arm/Group Title Acyclovir Then Valacyclovir Valacyclovir Then Acyclovir Total
Hide Arm/Group Description acyclovir 400 mg orally twice daily for 12 weeks, 2 week washout, then valacyclovir 1.5 g orally twice daily for 12 weeks valacyclovir 1.5 g orally twice daily for 12 weeks, 2 week washout, then acyclovir 400 mg orally twice daily for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 18 14 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants 14 participants 32 participants
<=18 years 0 0 0
Between 18 and 65 years 18 14 32
>=65 years 0 0 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 14 participants 32 participants
Female
11
  61.1%
7
  50.0%
18
  56.3%
Male
7
  38.9%
7
  50.0%
14
  43.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Kenya Number Analyzed 18 participants 14 participants 32 participants
18 14 32
Plasma HIV-1 RNA Level at Enrollment  
Mean (Standard Deviation)
Unit of measure:  Log10 copies/mL
Number Analyzed 18 participants 14 participants 32 participants
4.05  (0.72) 4.08  (0.85) 4.07  (0.75)
1.Primary Outcome
Title Mean Level of HIV-1 RNA in Plasma of Participants While on Acyclovir or Valacyclovir.
Hide Description Mean level of HIV-1 RNA in plasma of participants while on 400 mg twice daily of acyclovir versus while on 1.5 g twice daily of valacyclovir.
Time Frame Weekly for 12 weeks per intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acyclovir Valacyclovir
Hide Arm/Group Description:
acyclovir 400 mg twice daily 400 mg either in first intervention period or second
valacyclovir 1.5 g twice daily either in first intervention period or second
Overall Number of Participants Analyzed 32 31
Mean (95% Confidence Interval)
Unit of Measure: log10 copies/mL
3.56
(3.26 to 3.85)
2.94
(2.65 to 3.24)
2.Secondary Outcome
Title Safety of Valacyclovir 1.5 Gram Orally Twice Daily in HIV-1 Seropositive Persons.
Hide Description [Not Specified]
Time Frame 28 weeks
Outcome Measure Data Not Reported
Time Frame 28 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acyclovir Valacyclovir
Hide Arm/Group Description acyclovir 400 mg twice daily 400 mg either in first intervention period or second valacyclovir 1.5 g twice daily either in first intervention period or second
All-Cause Mortality
Acyclovir Valacyclovir
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Acyclovir Valacyclovir
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/31 (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 Valacyclovir
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/31 (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
Layout table for Results Point of Contact information
Name/Title: Connie Celum, MD, MPH
Organization: University of Washington
Phone: 206-520-3800
EMail: ccelum@uw.edu
Layout table for additonal information
Responsible Party: Connie Celum, University of Washington
ClinicalTrials.gov Identifier: NCT01026454     History of Changes
Other Study ID Numbers: 37162-A
First Submitted: December 2, 2009
First Posted: December 4, 2009
Results First Submitted: November 15, 2013
Results First Posted: March 5, 2014
Last Update Posted: April 8, 2014