Phase 2
N=20
Lubiprostone as a Modulator of Gut Microbial Translocation in HIV With Incomplete CD4 Recovery on Antiretroviral Therapy
HIV
Bottom Line
View on ClinicalTrials.gov: NCT01839734 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Changes in Gut Microbial Translocation (iFABP) — 145.76; 125.36; 151.5; 111.73 pg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lubiprostone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ruth M. Rothstein CORE Center
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Gut Microbial Translocation (iFABP) |
145.76; 125.36; 151.5; 111.73; -9.34; 14.47 | — |
| PRIMARY Changes in Gut Microbial Translocation (Zonulin) |
1; 3.24; 1.06; 0.98; 0.05; -1.80 | — |
| PRIMARY Changes in Gut Microbial Translocation (sCD14) |
10807.06; 12370.30; 11177.92; 11345.27; 247.20; -930.48 | — |
| PRIMARY Changes in Gut Microbial Translocation (sCD163) |
73.09; 51.75; 69.96; 56.74; -2.56; 4.99 | — |
| SECONDARY Changes in Systemic Inflammation (IL-6) |
1.46; 1.72; 1.67; 2.65; -0.12; -0.68 | — |
| SECONDARY Changes in Systemic Inflammation (hsCRP) |
25.99; 21.48; 27.72; 22.97; 0.51; 6.80 | — |
| SECONDARY Changes in Peripheral CD4+ |
333; 329.5; 339; 230; 5.5; -17.5 | — |
| SECONDARY Number of Participants With Adverse Events During Study Period |
0; 0 | — |
Summary
The use of lubiprostone will decrease the levels of immune activation in HIV-infected subjects with incomplete CD4+ T-cell recovery with antiretroviral therapy (ART).
* Lubiprostone will decrease levels of translocated gut microbial products in HIV-infected subjects with incomplete CD4+ T-cell recovery with ART.
* The decrease in levels of translocated gut microbial products will be associated with a decline in the levels of immune activation in HIV-infected subjects with incomplete CD4+ T-cell recovery with ART.
Eligibility Criteria
Inclusion Criteria
- HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.
- On tenofovir/emtricitabine/efavirenz single tablet combination therapy for at least 72 weeks prior to study entry.
- No plans to change the antiretroviral regimen at least in the next 3 months after study entry.
- CD4+ cell count 7.
- Receipt of antimicrobial therapy within 30 days prior to study entry.
NOTE: Antimicrobial use for prophylaxis of opportunistic infections, e.g., azithromycin or trimethoprim-sulfamethoxazole, is allowed.
- Active infection requiring the use of antibiotics within 30 days prior to study entry.
- Known allergy/sensitivity or any hypersensitivity to components of study drug or their formulation.
- Serious illness requiring systemic treatment and/or hospitalization within 14 days prior to entry.
- Use of any of the following medications for more than 3 consecutive days within the 60 days prior to study entry:
- Immunosuppressives (e.g., azathioprine, corticosteroids [physiologic replacement doses are allowed], cyclosporine, mycophenolate, NSAIDs (nonsteroidal anti-inflammatory drugs), sirolimus, sulfasalazine, tacrolimus)
- Immune modulators (e.g., cytokines [e.g., IL-2], granulocyte colony stimulating factor, growth hormone, tumor necrosis factor antagonists, thalidomide)
- Antineoplastic agents
- Probiotics (defined as products that contain significant amounts of live microorganisms and are ingested for specific health benefits, e.g., yogurt with live and active cultures, Lactobacillus GG, Saccharomyces boulardii)
- Anticoagulants (e.g., warfarin and heparin)
- Vaccinations within 1 week prior to the pre-entry or study entry visits.
NOTE: Subjects are encouraged to get the flu vaccine prior to study pre-entry visit.
- Participation on any HIV immunotherapy/therapeutic vaccination trials within 6 months prior to study entry.
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Breastfeeding.
Data sourced from ClinicalTrials.gov (NCT01839734). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.