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

History of Changes

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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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.
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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

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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 ]

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2. Secondary:

Difference in Number of Episodes of Genital Ulcer Disease Between Arms [ Time Frame: 2 years ]

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3. Secondary:

HIV-1 Viral Load Difference Between Arms [ Time Frame: baseline, 6 months, 12 months, 18 months, 24 months ]

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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

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Other Adverse Events

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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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More Information

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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:

Moriuchi M, Moriuchi H, Williams R, Straus SE. Herpes simplex virus infection induces replication of human immunodeficiency virus type 1. Virology. 2000 Dec 20;278(2):534-40.

Serwadda D, Gray RH, Sewankambo NK, Wabwire-Mangen F, Chen MZ, Quinn TC, Lutalo T, Kiwanuka N, Kigozi G, Nalugoda F, Meehan MP, Ashley Morrow R, Wawer MJ. Human immunodeficiency virus acquisition associated with genital ulcer disease and herpes simplex virus type 2 infection: a nested case-control study in Rakai, Uganda. J Infect Dis. 2003 Nov 15;188(10):1492-7. Epub 2003 Oct 28.

Stein DS, Graham NM, Park LP, Hoover DR, Phair JP, Detels R, Ho M, Saah AJ. The effect of the interaction of acyclovir with zidovudine on progression to AIDS and survival. Analysis of data in the Multicenter AIDS Cohort Study. Ann Intern Med. 1994 Jul 15;121(2):100-8.

Publications automatically indexed to this study:

Reynolds SJ, Makumbi F, Newell K, Kiwanuka N, Ssebbowa P, Mondo G, Boaz I, Wawer MJ, Gray RH, Serwadda D, Quinn TC. Effect of daily aciclovir on HIV disease progression in individuals in Rakai, Uganda, co-infected with HIV-1 and herpes simplex virus type 2: a randomised, double-blind placebo-controlled trial. Lancet Infect Dis. 2012 Jun;12(6):441-8. doi: 10.1016/S1473-3099(12)70037-3. Epub 2012 Mar 19.

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
Study First Received:	November 29, 2006
Results First Received:	July 18, 2012
Last Updated:	August 28, 2012
Health Authority:	United States: Federal Government Uganda: Research Ethics Committee Uganda: National Council for Science and Technology

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