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
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  
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
  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 ]

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     218/220  
Cardiac disorders      
Palpitations † 1    
# participants affected / at risk     32/220 (14.55%)     41/220 (18.64%)  
# events     41     58  
Ear and labyrinth disorders      
Hearing Loss † 1    
# participants affected / at risk     14/220 (6.36%)     15/220 (6.82%)  
# events     16     16  
Eye disorders      
Allergic conjunctivitis † 1    
# participants affected / at risk     33/220 (15.00%)     21/220 (9.55%)  
# events     41     29  
Gastrointestinal disorders      
Peptic ulcer disease † 1    
# participants affected / at risk     63/220 (28.64%)     60/220 (27.27%)  
# events     124     115  
Gastritis † 1    
# participants affected / at risk     27/220 (12.27%)     33/220 (15.00%)  
# events     31     42  
Gastrointestinal, other complaint † 1    
# participants affected / at risk     168/220 (76.36%)     157/220 (71.36%)  
# events     415     488  
General disorders      
Lymphadenopathy † 1    
# participants affected / at risk     25/220 (11.36%)     36/220 (16.36%)  
# events     30     47  
Decreased appetite † 1    
# participants affected / at risk     30/220 (13.64%)     29/220 (13.18%)  
# events     35     33  
General complaint, unspecified † 1    
# participants affected / at risk     190/220 (86.36%)     187/220 (85.00%)  
# events     791     810  
General complaint, unspecified † 1    
# participants affected / at risk     115/220 (52.27%)     123/220 (55.91%)  
# events     217     252  
Infections and infestations      
Malaria † 1    
# participants affected / at risk     107/220 (48.64%)     105/220 (47.73%)  
# events     211     204  
fungal skin infection † 1    
# participants affected / at risk     64/220 (29.09%)     46/220 (20.91%)  
# events     102     70  
angular chelitis † 1    
# participants affected / at risk     21/220 (9.55%)     34/220 (15.45%)  
# events     23     45  
Rhinitis † 1    
# participants affected / at risk     20/220 (9.09%)     18/220 (8.18%)  
# events     20     20  
Conjunctivitis † 1    
# participants affected / at risk     29/220 (13.18%)     32/220 (14.55%)  
# events     34     40  
Upper respiratory tract infection † 1    
# participants affected / at risk     212/220 (96.36%)     212/220 (96.36%)  
# events     1242     1226  
Oral candidiasis † 1    
# participants affected / at risk     15/220 (6.82%)     23/220 (10.45%)  
# events     26     40  
Intestinal helminthiasis † 1    
# participants affected / at risk     12/220 (5.45%)     20/220 (9.09%)  
# events     12     25  
Gastroenteritis † 1    
# participants affected / at risk     41/220 (18.64%)     33/220 (15.00%)  
# events     55     55  
Gonorrhea † 1    
# participants affected / at risk     14/220 (6.36%)     12/220 (5.45%)  
# events     20     14  
Genito-urinary disease (GUD) † 1    
# participants affected / at risk     39/220 (17.73%)     77/220 (35.00%)  
# events     52     131  
Vaginal candidiasis † 1    
# participants affected / at risk     80/220 (36.36%)     79/220 (35.91%)  
# events     134     159  
Urinary Tract Infection † 1    
# participants affected / at risk     36/220 (16.36%)     39/220 (17.73%)  
# events     48     55  
Injury, poisoning and procedural complications      
Traumatic injury † 1    
# participants affected / at risk     16/220 (7.27%)     16/220 (7.27%)  
# events     18     16  
Musculoskeletal and connective tissue disorders      
Arthritis † 1    
# participants affected / at risk     19/220 (8.64%)     15/220 (6.82%)  
# events     23     18  
Musculoskeletal joint pain, unspecified † 1    
# participants affected / at risk     165/220 (75.00%)     162/220 (73.64%)  
# events     470     472  
Nervous system disorders      
HIV neuritis † 1    
# participants affected / at risk     36/220 (16.36%)     22/220 (10.00%)  
# events     45     24  
post-herpetic neuralgia † 1    
# participants affected / at risk     7/220 (3.18%)     15/220 (6.82%)  
# events     8     20  
Nervous system, other complaint † 1    
# participants affected / at risk     55/220 (25.00%)     46/220 (20.91%)  
# events     76     68  
Reproductive system and breast disorders      
Pelvic inflammatory disease † 1    
# participants affected / at risk     21/220 (9.55%)     21/220 (9.55%)  
# events     22     24  
Vaginal discharge † 1    
# participants affected / at risk     10/220 (4.55%)     14/220 (6.36%)  
# events     10     16  
Genitourinary, other complaint † 1    
# participants affected / at risk     131/220 (59.55%)     140/220 (63.64%)  
# events     280     356  
Respiratory, thoracic and mediastinal disorders      
Respiratory complaint, unspecified † 1    
# participants affected / at risk     98/220 (44.55%)     82/220 (37.27%)  
# events     152     132  
Skin and subcutaneous tissue disorders      
Herpes zoster † 1    
# participants affected / at risk     4/220 (1.82%)     18/220 (8.18%)  
# events     4     18  
Papulo-pruritic eruption (PPE) † 1    
# participants affected / at risk     15/220 (6.82%)     22/220 (10.00%)  
# events     21     27  
Darkening nails † 1    
# participants affected / at risk     31/220 (14.09%)     32/220 (14.55%)  
# events     32     32  
Rash, unspecified † 1    
# participants affected / at risk     118/220 (53.64%)     119/220 (54.09%)  
# events     227     201  
Skin complaint, unspecified † 1    
# participants affected / at risk     123/220 (55.91%)     122/220 (55.45%)  
# events     213     212  
Events were collected by systematic assessment
1 Term from vocabulary, none



  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.


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