ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT00405821
Recruitment Status : Completed
First Posted : November 30, 2006
Results First Posted : September 28, 2012
Last Update Posted : September 28, 2012
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)

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.
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

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 ]
  Show Outcome Measure 1

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

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

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

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 )
First Submitted: November 29, 2006
First Posted: November 30, 2006
Results First Submitted: July 18, 2012
Results First Posted: September 28, 2012
Last Update Posted: September 28, 2012