A double-blind, multi-centre, randomized, placebo-controlled cross-over clinical trial to assess the efficacy of doxyPEP in reducing the incidence of bacterial STIs among MSM and TGW living with HIV in Belgium (DoxHIV study)

Conditions

bacterial sexually transmitted infections

Brief summary

Incidence rate ratio of symptomatic NG, CT, and all TP infections in the doxyPEP vs placebo arms

Detailed description

Rate ratio of tetracyclines, macrolides, cephalosporins, and penicillins in the doxyPEP vs placebo arms, MIC distribution (doxycycline/cefixime/ciprofloxacin) of commensal Neisseria spp. and E. coli in the doxyPEP vs placebo arms, Microbiota diversity, microbiota richness, abundance and diversity of Bifidobacteria, Fusobacterium, Lactobacillaceae, Enterobacteriaceae and Bacteroidaceae in both arms. Abundance of resistance genes (tetracyclines and other classes of antimicrobials) in both arms, Incidence rate ratio of symptomatic NG infections in the doxyPEP vs placebo arms, Incidence rate ratio of symptomatic CT infections in the doxyPEP vs placebo arms, Incidence rate ratio of symptomatic TP infections in the doxyPEP vs placebo arms, Incidence rate ratio of all NG infections in the doxyPEP vs placebo arms, Incidence rate ratio of all CT infections in the doxyPEP vs placebo arms, Incidence rate ratio of all TP infections in the doxyPEP vs placebo arms, Tetracycline MIC distribution of NG isolates in the doxyPEP vs placebo arms

Related papers

No related papers found yet.

Papers published before 2002-11-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGPlacebo capsules for Doxycycline 200 mg (Empty Hpmc capsule

DRUGvcaps plus

DRUGswedish orange filled with microcrystalline cellulose)

DRUGDoxycycline EG 100 mg tabletten

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence rate ratio of symptomatic NG, CT, and all TP infections in the doxyPEP vs placebo arms	—

Secondary

Measure	Time frame
Rate ratio of tetracyclines, macrolides, cephalosporins, and penicillins in the doxyPEP vs placebo arms, MIC distribution (doxycycline/cefixime/ciprofloxacin) of commensal Neisseria spp. and E. coli in the doxyPEP vs placebo arms, Microbiota diversity, microbiota richness, abundance and diversity of Bifidobacteria, Fusobacterium, Lactobacillaceae, Enterobacteriaceae and Bacteroidaceae in both arms. Abundance of resistance genes (tetracyclines and other classes of antimicrobials) in both arms, Incidence rate ratio of symptomatic NG infections in the doxyPEP vs placebo arms, Incidence rate ratio of symptomatic CT infections in the doxyPEP vs placebo arms, Incidence rate ratio of symptomatic TP infections in the doxyPEP vs placebo arms, Incidence rate ratio of all NG infections in the doxyPEP vs placebo arms, Incidence rate ratio of all CT infections in the doxyPEP vs placebo arms, Incidence rate ratio of all TP infections in the doxyPEP vs placebo arms, Tetracycline MIC distribution of N	—

Measure

Time frame

Rate ratio of tetracyclines, macrolides, cephalosporins, and penicillins in the doxyPEP vs placebo arms, MIC distribution (doxycycline/cefixime/ciprofloxacin) of commensal Neisseria spp. and E. coli in the doxyPEP vs placebo arms, Microbiota diversity, microbiota richness, abundance and diversity of Bifidobacteria, Fusobacterium, Lactobacillaceae, Enterobacteriaceae and Bacteroidaceae in both arms. Abundance of resistance genes (tetracyclines and other classes of antimicrobials) in both arms, Incidence rate ratio of symptomatic NG infections in the doxyPEP vs placebo arms, Incidence rate ratio of symptomatic CT infections in the doxyPEP vs placebo arms, Incidence rate ratio of symptomatic TP infections in the doxyPEP vs placebo arms, Incidence rate ratio of all NG infections in the doxyPEP vs placebo arms, Incidence rate ratio of all CT infections in the doxyPEP vs placebo arms, Incidence rate ratio of all TP infections in the doxyPEP vs placebo arms, Tetracycline MIC distribution of N

—

Countries

Belgium

Outcome results

None listed