Trial · NCT03029689
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
NCT03029689, Phase 3, Completed, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia; results first posted 2025-04-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT03029689. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03029689
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT03029689
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 61 participants, actual
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Conditions
- HIV
- Interventions
- Raltegravir, Placebo, Current ART
- First posted
- 2017-01-24
- Last updated
- 2025-06-17
- Results first posted
- 2025-04-13
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Bacterial Gene Richness (Observed Unique Genes). Analysis of the Composition, Structure and Function of the Intestinal Microbiome. * | From baseline to 48 weeks | -\* Structure and composition of the microbiome. DNA will be extracted and purified from fecal samples and cryopreserved at -80ºC until amplification. The purified DNA will be amplified using Illumina-tagged primers to amplify the V3 and V4 16S ribosomal DNA (rDNA) regions. PCR reactions will be performed in triplicate to preserve diversity. Pooled triplicates will be sequenced ensuring adequate sampling depth. -Function of the bacteriome. The gene content will be inferred from the abundance of each bacteria in the intestinal bacteriome according to the 16S rDNA information |
| Secondary | Association of the Gut Microbiome With Inflammation Markers | From baseline to week 48 | IL-6, IP-10 |
| Secondary | Association of the Gut Microbiome With Coagulation | From baseline to 48 weeks | D-Dimer |
| Secondary | Association of the Gut Microbiome With Enterocyte Damage | From baseline to 48 weeks | Intestinal Fatty Acid Binding Protein (I-FABP) |
| Secondary | Association of the Gut Microbiome With Bacterial Translocation and Monocyte Activation | From baseline to 48 weeks | LPS-binding protein (LBP), soluble CD14 |
| Secondary | Mean Fluorescence Intensity (MFI) Measure of Maturation, Activation, Exhaustion and Immune Senescence Markers in CD4+ and CD8+ T-cells | Differences at week 48 | CCR7, CD28, CD27, HLA-DR, CD38, PD-1, CD57 |
| Secondary | Association of the Gut Microbiome Composition and Richness With CD4 and CD8+ Counts. | Baseline | CD4 and CD8+ counts |
| Secondary | Other Estimators of Richness and Diversity | From baseline to 48 weeks | Shannon |
| Secondary | Association of the Gut Microbiome Composition and Richness With CD4/CD8+ Cell Ratio. | Baseline | CD4/CD8+ cell ratio |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Bacterial Gene Richness (Observed Unique Genes). Analysis of the Composition, Structure and Function of the Intestinal Microbiome. * | From baseline to 48 weeks | Number of unique genes detected | MEDIAN | |
| SECONDARY | Association of the Gut Microbiome With Inflammation Markers | From baseline to week 48 | pg/ml | MEDIAN | |
| SECONDARY | Association of the Gut Microbiome With Coagulation | From baseline to 48 weeks | ug/ml | MEDIAN | |
| SECONDARY | Association of the Gut Microbiome With Enterocyte Damage | From baseline to 48 weeks | ng/ml | MEDIAN | |
| SECONDARY | Association of the Gut Microbiome With Bacterial Translocation and Monocyte Activation | From baseline to 48 weeks | ng/ml | MEDIAN | |
| SECONDARY | Mean Fluorescence Intensity (MFI) Measure of Maturation, Activation, Exhaustion and Immune Senescence Markers in CD4+ and CD8+ T-cells | Differences at week 48 | MFI | MEDIAN | |
| SECONDARY | Association of the Gut Microbiome Composition and Richness With CD4 and CD8+ Counts. | Baseline | cells/mm^3 of blood | MEDIAN | |
| SECONDARY | Other Estimators of Richness and Diversity | From baseline to 48 weeks | The Shannon Diversity Index (SDI), also known as Shannon-Weaver or Shannon-Wiener Index, is a commonly used metric in ecology and microbiome research to quantify microbial diversity within a sample (alpha diversity). It takes into account both richness (the number of different species and evenness (the relative abundance distribution of species). Higher SDI values reflect greater microbial diversity, while lower SDI values may indicate dysbiosis or a disrupted microbial community. | Shannon index | MEDIAN |
| SECONDARY | Association of the Gut Microbiome Composition and Richness With CD4/CD8+ Cell Ratio. | Baseline | CD4+/CD8+ ratio | Ratio | MEDIAN |
Source ClinicalTrials.gov
Results by group82
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Bacterial Gene Richness (Observed Unique Genes). Analysis of the Composition, Structure and Function of the Intestinal Microbiome. * | Current ART + Raltegravir | Gene richness at baseline | 768358 | Inter-Quartile Range 663708 to 879113 | Number of unique genes detected |
| Bacterial Gene Richness (Observed Unique Genes). Analysis of the Composition, Structure and Function of the Intestinal Microbiome. * | Current ART + Placebo | Gene richness at baseline | 730732 | Inter-Quartile Range 552699 to 869340 | Number of unique genes detected |
| Bacterial Gene Richness (Observed Unique Genes). Analysis of the Composition, Structure and Function of the Intestinal Microbiome. * | Current ART + Raltegravir | Gene richness at timepoint 12 | 767756 | Inter-Quartile Range 600703 to 834276 | Number of unique genes detected |
| Bacterial Gene Richness (Observed Unique Genes). Analysis of the Composition, Structure and Function of the Intestinal Microbiome. * | Current ART + Placebo | Gene richness at timepoint 12 | 808911 | Inter-Quartile Range 721094 to 832215 | Number of unique genes detected |
| Bacterial Gene Richness (Observed Unique Genes). Analysis of the Composition, Structure and Function of the Intestinal Microbiome. * | Current ART + Raltegravir | Gene richness at timepoint 24 | 724452 | Inter-Quartile Range 605639 to 825037 | Number of unique genes detected |
| Bacterial Gene Richness (Observed Unique Genes). Analysis of the Composition, Structure and Function of the Intestinal Microbiome. * | Current ART + Placebo | Gene richness at timepoint 24 | 777452 | Inter-Quartile Range 695461 to 872279 | Number of unique genes detected |
| Bacterial Gene Richness (Observed Unique Genes). Analysis of the Composition, Structure and Function of the Intestinal Microbiome. * | Current ART + Raltegravir | Gene richness at timepoint 48 | 718824 | Inter-Quartile Range 624788 to 848524 | Number of unique genes detected |
| Bacterial Gene Richness (Observed Unique Genes). Analysis of the Composition, Structure and Function of the Intestinal Microbiome. * | Current ART + Placebo | Gene richness at timepoint 48 | 860913 | Inter-Quartile Range 745053 to 882858 | Number of unique genes detected |
| Association of the Gut Microbiome With Inflammation Markers | Current ART + Raltegravir | IL-6 at baseline | 1.32 | Inter-Quartile Range 1.14 to 1.78 | pg/ml |
| Association of the Gut Microbiome With Inflammation Markers | Current ART + Placebo | IL-6 at baseline | 1.53 | Inter-Quartile Range 1.41 to 1.78 | pg/ml |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Current ART + Raltegravir | 40 | |
| Overall Study | STARTED | Current ART + Placebo | 21 | |
| Overall Study | COMPLETED | Current ART + Raltegravir | 37 | |
| Overall Study | COMPLETED | Current ART + Placebo | 17 | |
| Overall Study | NOT COMPLETED | Current ART + Raltegravir | 3 | |
| Overall Study | NOT COMPLETED | Current ART + Placebo | 4 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Adverse event not related to the treatment | Investigations | Current ART + Raltegravir | 1 | 38 | 1 |
| other | Adverse event not related to the treatment | Investigations | Current ART + Placebo | 1 | 18 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Current ART + Raltegravir | 0 | 37 |
| Total, all-cause mortality | Current ART + Placebo | 0 | 17 |
| Total, other adverse events | Current ART + Raltegravir | 1 | 38 |
| Total, other adverse events | Current ART + Placebo | 1 | 18 |
| Total, serious adverse events | Current ART + Raltegravir | 0 | 37 |
| Total, serious adverse events | Current ART + Placebo | 0 | 17 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Current ART + Raltegravir vs Current ART + Placebo: deaths from any cause | Trial comparisons |
| Current ART + Raltegravir vs Current ART + Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03029689
GET https://conductscience.org/api/trials/v1/NCT03029689/results?page=2