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Acyclovir to Treat Patients Co-infected With HIV and Herpes Viruses in Uganda

This study has been completed.
Sponsor:
Collaborators:
University of Washington
Johns Hopkins University
Translational Genomics Research Institute, Phoenix, Arizona.
Information provided by (Responsible Party):
Steven Reynolds, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00405821
First received: November 29, 2006
Last updated: August 28, 2012
Last verified: August 2012
History of Changes
Results First Received: July 18, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV Infections
Herpes Genitalis
Interventions: Drug: Acyclovir
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
440 HIV+ subjects recruited in rural Rakai, Uganda within the Rakai Health Sciences Program mobile medical clinic during May 2007 thru November 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All subjects were randomized to study arm, and initiated study treatment at the time of enrollment.

Reporting Groups
  Description
Acyclovir 400mg Tablet Twice Daily No text entered.
Placebo Tablet Twice Daily No text entered.

Participant Flow:   Overall Study
    Acyclovir 400mg Tablet Twice Daily     Placebo Tablet Twice Daily  
STARTED     220     220  
COMPLETED     198     198  
NOT COMPLETED     22     22  
Death                 5                 7  
Lost to Follow-up                 7                 7  
Protocol Violation                 1                 0  
initiated ART                 9                 8  



  Baseline Characteristics
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Reporting Groups
  Description
Acyclovir 400mg Tablet Twice Daily No text entered.
Placebo Tablet Twice Daily No text entered.
Total Total of all reporting groups

Baseline Measures
    Acyclovir 400mg Tablet Twice Daily     Placebo Tablet Twice Daily     Total  
Number of Participants  
[units: participants]
 		  220     220     440  
Age, Customized  
[units: participants]
 		     
20-29 years     46     44     90  
30-39 years     94     93     187  
40-49 years     54     53     107  
50+ years     26     30     56  
Gender  
[units: participants]
 		     
Female     150     161     311  
Male     70     59     129  



  Outcome Measures
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1.  Primary:   Progression to AIDS (CD4+ Less Than 250 Cells/Microliter or World Health Org Stage IV dx, Excluding Esophageal Candidiasis)   [ Time Frame: 2 years ]
  Show Outcome Measure 1

2.  Secondary:   Difference in Number of Episodes of Genital Ulcer Disease Between Arms   [ Time Frame: 2 years ]
  Show Outcome Measure 2

3.  Secondary:   HIV-1 Viral Load Difference Between Arms   [ Time Frame: baseline, 6 months, 12 months, 18 months, 24 months ]
  Hide Outcome Measure 3

Measure Type Secondary
Measure Title HIV-1 Viral Load Difference Between Arms
Measure Description We measured mean annual rate of change in log10 viral load (copies/mL) for each group. We assessed difference in annual rate of change in log10 viral load (copies/mL) between groups.
Time Frame baseline, 6 months, 12 months, 18 months, 24 months  
Safety Issue No  

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.
We measured viral load at baseline and at 6 monthly follow-up visits during 24 months of follow-up for all subjects randomized on this study.

Reporting Groups
  Description
Acyclovir 400mg Tablet Twice Daily No text entered.
Placebo Tablet Twice Daily No text entered.

Measured Values
    Acyclovir 400mg Tablet Twice Daily     Placebo Tablet Twice Daily  
Number of Participants Analyzed  
[units: participants]
 		  220     220  
HIV-1 Viral Load Difference Between Arms  
[units: log10 (copies/mL)]
Mean ( 95% Confidence Interval ) 		  -0.061  
  ( -0.250 to 0.129 )   		  0.402  
  ( 0.212 to 0.592 )  


Statistical Analysis 1 for HIV-1 Viral Load Difference Between Arms
Groups [1] All groups
Method [2] t-test, 2 sided
P Value [3] 0.05
Mean Difference (Final Values) [4] -0.463
95% Confidence Interval ( -0.731 to -0.194 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Null hypothesis is no difference in annual rate of change in log10 viral load by arm.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



4.  Secondary:   Toxicity of Acyclovir   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Adherence to Acyclovir   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Virologic and Immunologic Responses to ART in Those Who Progress to CD+4 Less Than 250cells/mL   [ Time Frame: 6 months and 12 moths post ART initiation ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Steven Reynolds
Organization: NIAID
phone: 256-772-220-087
e-mail: sjreynolds@niaid.nih.gov


Publications:

Publications automatically indexed to this study:


Responsible Party: Steven Reynolds, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00405821     History of Changes
Other Study ID Numbers: 999907032, 07-I-N032
Study First Received: November 29, 2006
Results First Received: July 18, 2012
Last Updated: August 28, 2012
Health Authority: United States: Federal Government
Uganda: Research Ethics Committee
Uganda: National Council for Science and Technology