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HPTN 056
Characterization of Baseline
Mucosal Indices of Injury and Inflammation in Men for Use in Rectal Microbicide
Trials
What is
HPTN 056?
The
development of new rectal microbicides will involve defining the safety
and efficacy profile of each agent. The safety profile for a rectal
microbicide may differ from that needed for a vaginal microbicide as the
two sites differ anatomically and physiologically. It is known that
microbicides may cause local mucosal irritation and the rationale for the
aims of HPTN 056 is to define baseline values for a broad range of
immunological, virological and histopathological parameters that might be
perturbed following application of a rectal microbicide.
The
primary objective of HPTN 056 is to determine the variability and contrast
the differences between study groups of a range of immunological,
virological and histopathological parameters in multiple rectal tissue
biopsies from two sites in the recto-sigmoid colon (10 cm and 30cm)
measured three times over 6 weeks.
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Protocol Status:
Participants Off Study & Primary Analysis Complete
Study
Summary
Study Purpose: The primary purpose of this study is to identify mucosal indices that would be valuable in the safety evaluation of rectal microbicides and to determine the sensitivity and variability of those assays.
Study Design: Observational study with endoscopic collection of distal colonic and rectal tissue biopsies over a 6-week period.
Study Population: HIV infected and uninfected men who have sex with men (MSM) aged 18-50 years old.
Study Size: A total of 16 participants will be enrolled into four groups of four participants:· Group 1a: HIV-seronegative, practicing anal-receptive sex; Group 1b: HIV-seronegative, not practicing anal-receptive sex; Group 2a: HIV-seropositive, anal-receptive active subjects with high plasma viral burden (>10,000 copies RNA / ml plasma); Group 2b: HIV-seropositive, anal-receptive active subjects with low plasma viral burden (<50 copies RNA / ml plasma)
Study Duration: Accrual will require approximately four months and each participant will be followed for six weeks. Therefore the study should be completed within six months.
Treatment Regimen: Not applicable
Primary Objectives: To determine the variability and contrast the differences of a range of immunological, virological, and histopathological parameters in multiple rectal tissue biopsies collected at two sites in the recto-sigmoid colon (10 cm and 30 cm).
Secondary Objectives: To determine biological variability between groups and stability of defined measures over time by assaying samples at both sites from relevant study groups measured three times over six weeks.
Protocol Co-Chair:
Ian McGowan
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Protocol Chair:
Peter Anton
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CORE Protocol Specialist:
Scott Rose
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