HPTN 056

Characterization of Baseline Mucosal Indices of Injury and Inflammation in Men for Use in Rectal Microbicide Trials

Study Summary
Study Documents - Study Details* - Key Study Personnel* - Study SitesPublications
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What was HPTN 056?

An observational study with endoscopic collection of distal colonic and rectal tissue biopsies over a 6-week period 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.

Who participated in the study?

HIV infected and uninfected men who have sex with men (MSM) aged 18-50 years old.

What happened during the study?

Sixteen male participants were enrolled into 4 groups defined by HIV status, viral load, and sexual activity. Each participant underwent 3 flexible sigmoidoscopies at 2-week intervals with collection of blood, intestinal biopsies, and rectal secretions.

Results

Qualitative histology demonstrated minimal inflammation in >95% of biopsies and remained stable throughout the study period. ICC for the tissue cytokine mRNA measurements and several T-cell phenotypic markers was >0.7, indicating stability over time. Mucosal CD4 lymphopenia was seen in the HIV-positive participants and was more pronounced in those with higher viral loads.

Why was this study important?

The development of new rectal microbicides involve defining the safety and efficacy profile of each agent – safety had to be measured in order to create an effective microbicide.

Study Documents

Study Details

Protocol Status: Concluded
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.

Key Study Personnel

Peter Anton, Protocol Chair
Ian M. McGowan, Protocol Co-Chair
Scott Rose, CORE Protocol Specialist