N/A
Completed N=8
Pilot Study on the Effect of Adding Raltegravir +/- a Second Drug on HIV Levels in the Gut
Source: ClinicalTrials.gov NCT00884793 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcomePrimary: Number of Subjects Who Had a Decrease in HIV RNA Per Million CD4+ T Cells in the Ileum — 5 participants
Summary
The "PLUS" study is a pilot study to measure the effect of therapy intensification (with raltegravir and optional second agent) on HIV levels in the gut and blood in patients on antiretroviral therapy (ART) with viral load < 50 copies/mL (herein referred to as "suppressed"). We hypothesize that there is ongoing replication in the gut despite suppressive ART and that this replication can be inhibited by the addition of one or two new antiretroviral drugs whose activity affects a distinct part of the viral life cycle. All study participants will have upper and lower endoscopy at baseline (before intensification) and after intensification. These endoscopies will be used to obtain gut tissue and single cells (for CD4+ cells) .
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Who Had a Decrease in HIV RNA Per Million CD4+ T Cells in the Ileum |
5 | — |
| SECONDARY Number of Subjects Who Experienced an Increase in CD4+ T Cells (as a % of All Cells) in the Ileum. |
6 | — |
| SECONDARY Number of Subjects Who Experienced an Increase in CD4% in the Ileum. |
5 | — |
| SECONDARY Average Change in "Activated" (CD38+HLADR+) CD8+ T Cells in the Ileum |
-5.4 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 to 65 years
- Infection with HIV-1, as documented by a licensed ELISA and confirmed by a Western blot or HIV-1 RNA at any time prior to study entry
- On ART for at least 12 months prior to study entry with a regimen that includes at least two NRTIs and either an NNRTI or PI
- No change in ART for at least 3 months prior to study entry.
- CD4+ T cell count of 200 or greater within 30 days prior to study entry.
- HIV-1 RNA level consistently below the limit of detection of commercial ultrasensitive assays ( 1.6
- Current use of antiplatelet agents (aspirin, other NSAIDS, clopidogrel (Plavix), other antiplatelet agents) or anticoagulants (heparin, low molecular weight heparin, warfarin, lepirudin, or other anticoagulants) and inability to temporarily hold such medications for endoscopy.
- Active angina, unstable angina, or MI within 2 months prior to study entry
- Decompensated CHF
- Respiratory insufficiency with FEV1 350 mg/dL
- Prior use of raltegravir
- Any condition that, in the opinion of the infectious disease (ID) specialist, would be a contraindication to raltegravir. These conditions may include, but are not limited to: unstable clinical condition (such as recent hospitalization, cancer with need for chemotherapy or radiation); severe hepatic insufficiency; need for contraindicated medicines; breastfeeding; or high risk for myopathy or rhabdomyolysis.
- Calculated creatinine clearance (CrCl) 3x the upper limit of normal (ULN).
- LDL > 200 mg/dL or TG > 400 mg/dL in fasting lipids, as measured within three months prior to screening or at the time of screening
- Plan to change the background ART within 16 weeks after study entry
- Receipt of any HIV vaccine
- Receipt of a non-HIV vaccine within 30 days prior to study entry
- An opportunistic infection within 60 days prior to study entry
- Use of significant immunosuppressive medications (such as systemic corticosteroids, tacrolimus, sirolimus, mycophenolate, azathioprine, interferon, and cancer chemotherapy) within 60 days prior to study entry.
- Active drug or alcohol abuse that, in the opinion of the investigator, would interfere with adherence to the requirements of the study
Data sourced from ClinicalTrials.gov (NCT00884793). 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. Informational only — not medical advice.