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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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

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
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

  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
No text entered.

  More Information