Clinical trial to evaluate the effect of Raltegravir intensification (1.200 mg QD) on the gut microbiota of chronically HIV-1 infected subject over time

Randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of Raltegravir intensification (1.200 mg QD) on the gut microbiota of chronically HIV-1 infected subject over time: THE RAGTIME STUDY

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002722-36-ES

Enrollment

Unknown

Registered

2017-01-04

Start date

2017-03-29

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1 MedDRA version: 19.0 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862

Interventions

Product Name: Raltegravir Product Code: MK-0518 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: RALTEGRAVIR CAS Number: 518048-05-0 Concentration unit: mg milligram(s) Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age =18 years old 2. Documented HIV infection 3. Stable antiretroviral treatment including PIi/r or NNRTIi-based 3 drugs ART for at least 6 months. 4. Plasma HIV-1 RNA load =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. PI/r monoterapy 2. INSTI therapy during the previous 6 months 3. Evidence of previous INSTI resistance 4. Creatine clearance <50 mL/min 5. Child- Pugh B or C 6. History of active uncontrolled GI disorders or diseases including: 6.1. Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the previous 5 years. 6.2. Any major bowel resection at any time 6.3. Any chronic digestive disease such as peptic ulcer, Crohn’s disease, ulcerative colitis, coeliac disease, confirmed intolerance to lactose or indeterminate colitis. 6.4. Persistent infectious gastroenteritis, colitis or gastritis; persistent or chronic diarrhea of unknown etiology; Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated); 6.5. Irritable bowel syndrome (moderate-severe) 6.6. Chronic constipation 6.7. Active proctitis 7. Antibiotic therapy within the previous 2 months 8. In women, pregnancy or breastfeeding

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the ability of raltegravir intensification to increase gut microbiome richness and modify the gut microbiome composition of people living with HIV receiving stable ART.;Secondary Objective: To correlate changes in the gut microbiota composition and richness with markers of inflammation, coagulation, enterocyte damage, bacterial translocation and T-cell maturation, activation, exhaustion and senescence during raltegravir intensification.;Primary end point(s): Increase in bacterial richness (observed species).;Timepoint(s) of evaluation of this end point: At week 48, relative to baseline (week 0).	—

Measure

Time frame

Main Objective: To evaluate the ability of raltegravir intensification to increase gut microbiome richness and modify the gut microbiome composition of people living with HIV receiving stable ART.;Secondary Objective: To correlate changes in the gut microbiota composition and richness with markers of inflammation, coagulation, enterocyte damage, bacterial translocation and T-cell maturation, activation, exhaustion and senescence during raltegravir intensification.;Primary end point(s): Increase in bacterial richness (observed species).;Timepoint(s) of evaluation of this end point: At week 48, relative to baseline (week 0).

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Secondary

Measure	Time frame
Secondary end point(s): •Longitudinal changes in: -Gut bacterial composition -Gut bacterial function -Other estimators of richness and diversity: Chao1, ACE, Shannon, 1/Simpson. •Association of the gut microbiome composition and richness with: -Inflammation: IL-6, IP-10 -Coagulation: D-Dimer -Enterocyte damage: Intestinal Fatty Acid Binding Protein (I-FABP) -Bacterial translocation and monocyte activation: LPS-binding protein (LBP), soluble CD14. -Maturation, activation, exhaustion and immune senescence in CD4+ and CD8+ T-cells: CD3+, CD4+, CD8+, CD45RA, CCR7, CD28, CD27, HLA-DR, CD38, PD-1, CD57. -CD4 and CD8+ counts -CD4+/CD8+ ratio;Timepoint(s) of evaluation of this end point: Baseline, weeks 12, 24, 48	—

Measure

Time frame

Secondary end point(s): •Longitudinal changes in: -Gut bacterial composition -Gut bacterial function -Other estimators of richness and diversity: Chao1, ACE, Shannon, 1/Simpson. •Association of the gut microbiome composition and richness with: -Inflammation: IL-6, IP-10 -Coagulation: D-Dimer -Enterocyte damage: Intestinal Fatty Acid Binding Protein (I-FABP) -Bacterial translocation and monocyte activation: LPS-binding protein (LBP), soluble CD14. -Maturation, activation, exhaustion and immune senescence in CD4+ and CD8+ T-cells: CD3+, CD4+, CD8+, CD45RA, CCR7, CD28, CD27, HLA-DR, CD38, PD-1, CD57. -CD4 and CD8+ counts -CD4+/CD8+ ratio;Timepoint(s) of evaluation of this end point: Baseline, weeks 12, 24, 48

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Countries

Spain

Contacts

Public ContactCRA

Fundació Lluita contra la SIDA

jtoro@fls-rs.com+3493497 84 14

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026