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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
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
Results First Received: July 18, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV Infections
Herpes Genitalis
Interventions: Drug: Acyclovir
Drug: Placebo

  Participant Flow
  Hide Participant Flow

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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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 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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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 ]

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

Measure Type Secondary
Measure Title Difference in Number of Episodes of Genital Ulcer Disease Between Arms
Measure Description We calculated incidence rate for each treatment arm for episodes of genital ulcer disease, and incidence rate ratio.
Time Frame 2 years  

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 conducted monthly clinical assessment for GUD on all randomized subjects during their entire follow-up period on this trial. The number of episodes of GUD is shown below.

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 
Participants Analyzed 
[Units: Participants]
 220   220 
Difference in Number of Episodes of Genital Ulcer Disease Between Arms 
[Units: Episodes]
 27   47 


Statistical Analysis 1 for Difference in Number of Episodes of Genital Ulcer Disease Between Arms
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] rate ratio with 95% CI
P Value [4] <0.05
Risk Ratio (RR) [5] 0.31
95% Confidence Interval 0.19 to 0.48
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Null hypothesis is no difference by treatment arm in rate of GUD.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  we included multiple GUD events per subject in the estimate of GUD incidence
[5] Other relevant estimation information:
  No text entered.



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

4.  Secondary:   Toxicity of Acyclovir   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Adherence to Acyclovir   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

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 reported.   Anticipated Reporting Date:   No text entered.  


  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
No text entered.


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


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 by ClinicalTrials.gov Identifier (NCT Number):

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 ( Other Identifier: NIAID Intramural IRB )
Study First Received: November 29, 2006
Results First Received: July 18, 2012
Last Updated: August 28, 2012