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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;   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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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
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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 ]

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.   Safety Issue:   Yes

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


  Serious Adverse Events


  Other Adverse Events
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Time Frame maximum follow-up time on this study ranged from 24 months to 41 months depending on time of enrollment.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5  

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

Other Adverse Events
    Acyclovir 400mg Tablet Twice Daily   Placebo Tablet Twice Daily
Total, other (not including serious) adverse events     
# participants affected / at risk   219/220 (99.55%)   218/220 (99.09%) 
Cardiac disorders     
Palpitations †     
# participants affected / at risk   32/220 (14.55%)   41/220 (18.64%) 
# events   41   58 
Ear and labyrinth disorders     
Hearing Loss †     
# participants affected / at risk   14/220 (6.36%)   15/220 (6.82%) 
# events   16   16 
Eye disorders     
Allergic conjunctivitis †     
# participants affected / at risk   33/220 (15.00%)   21/220 (9.55%) 
# events   41   29 
Gastrointestinal disorders     
Peptic ulcer disease †     
# participants affected / at risk   63/220 (28.64%)   60/220 (27.27%) 
# events   124   115 
Gastritis †     
# participants affected / at risk   27/220 (12.27%)   33/220 (15.00%) 
# events   31   42 
Gastrointestinal, other complaint †     
# participants affected / at risk   168/220 (76.36%)   157/220 (71.36%) 
# events   415   488 
General disorders     
Lymphadenopathy †     
# participants affected / at risk   25/220 (11.36%)   36/220 (16.36%) 
# events   30   47 
Decreased appetite †     
# participants affected / at risk   30/220 (13.64%)   29/220 (13.18%) 
# events   35   33 
General complaint, unspecified †     
# participants affected / at risk   190/220 (86.36%)   187/220 (85.00%) 
# events   791   810 
General complaint, unspecified †     
# participants affected / at risk   115/220 (52.27%)   123/220 (55.91%) 
# events   217   252 
Infections and infestations     
Malaria †     
# participants affected / at risk   107/220 (48.64%)   105/220 (47.73%) 
# events   211   204 
fungal skin infection †     
# participants affected / at risk   64/220 (29.09%)   46/220 (20.91%) 
# events   102   70 
angular chelitis †     
# participants affected / at risk   21/220 (9.55%)   34/220 (15.45%) 
# events   23   45 
Rhinitis †     
# participants affected / at risk   20/220 (9.09%)   18/220 (8.18%) 
# events   20   20 
Conjunctivitis †     
# participants affected / at risk   29/220 (13.18%)   32/220 (14.55%) 
# events   34   40 
Upper respiratory tract infection †     
# participants affected / at risk   212/220 (96.36%)   212/220 (96.36%) 
# events   1242   1226 
Oral candidiasis †     
# participants affected / at risk   15/220 (6.82%)   23/220 (10.45%) 
# events   26   40 
Intestinal helminthiasis †     
# participants affected / at risk   12/220 (5.45%)   20/220 (9.09%) 
# events   12   25 
Gastroenteritis †     
# participants affected / at risk   41/220 (18.64%)   33/220 (15.00%) 
# events   55   55 
Gonorrhea †     
# participants affected / at risk   14/220 (6.36%)   12/220 (5.45%) 
# events   20   14 
Genito-urinary disease (GUD) †     
# participants affected / at risk   39/220 (17.73%)   77/220 (35.00%) 
# events   52   131 
Vaginal candidiasis †     
# participants affected / at risk   80/220 (36.36%)   79/220 (35.91%) 
# events   134   159 
Urinary Tract Infection †     
# participants affected / at risk   36/220 (16.36%)   39/220 (17.73%) 
# events   48   55 
Injury, poisoning and procedural complications     
Traumatic injury †     
# participants affected / at risk   16/220 (7.27%)   16/220 (7.27%) 
# events   18   16 
Musculoskeletal and connective tissue disorders     
Arthritis †     
# participants affected / at risk   19/220 (8.64%)   15/220 (6.82%) 
# events   23   18 
Musculoskeletal joint pain, unspecified †     
# participants affected / at risk   165/220 (75.00%)   162/220 (73.64%) 
# events   470   472 
Nervous system disorders     
HIV neuritis †     
# participants affected / at risk   36/220 (16.36%)   22/220 (10.00%) 
# events   45   24 
post-herpetic neuralgia †     
# participants affected / at risk   7/220 (3.18%)   15/220 (6.82%) 
# events   8   20 
Nervous system, other complaint †     
# participants affected / at risk   55/220 (25.00%)   46/220 (20.91%) 
# events   76   68 
Reproductive system and breast disorders     
Pelvic inflammatory disease †     
# participants affected / at risk   21/220 (9.55%)   21/220 (9.55%) 
# events   22   24 
Vaginal discharge †     
# participants affected / at risk   10/220 (4.55%)   14/220 (6.36%) 
# events   10   16 
Genitourinary, other complaint †     
# participants affected / at risk   131/220 (59.55%)   140/220 (63.64%) 
# events   280   356 
Respiratory, thoracic and mediastinal disorders     
Respiratory complaint, unspecified †     
# participants affected / at risk   98/220 (44.55%)   82/220 (37.27%) 
# events   152   132 
Skin and subcutaneous tissue disorders     
Herpes zoster †     
# participants affected / at risk   4/220 (1.82%)   18/220 (8.18%) 
# events   4   18 
Papulo-pruritic eruption (PPE) †     
# participants affected / at risk   15/220 (6.82%)   22/220 (10.00%) 
# events   21   27 
Darkening nails †     
# participants affected / at risk   31/220 (14.09%)   32/220 (14.55%) 
# events   32   32 
Rash, unspecified †     
# participants affected / at risk   118/220 (53.64%)   119/220 (54.09%) 
# events   227   201 
Skin complaint, unspecified †     
# participants affected / at risk   123/220 (55.91%)   122/220 (55.45%) 
# events   213   212 
Events were collected by systematic assessment



  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
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