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

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ClinicalTrials.gov Identifier: NCT00405821
Recruitment Status : Completed
First Posted : November 30, 2006
Results First Posted : September 28, 2012
Last Update Posted : September 28, 2012
University of Washington
Johns Hopkins University
Translational Genomics Research Institute
Information provided by (Responsible Party):
Steven Reynolds, National Institutes of Health Clinical Center (CC)

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

  Baseline Characteristics

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.
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Reporting Groups
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 
[Units: Participants]
Female   150   161   311 
Male   70   59   129 

  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 ]

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

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