Phase 4
N=45
Maraviroc as an Immunomodulatory Drug for Antiretroviral-treated HIV Infected Patients Exhibiting Immunologic Failure
HIV Infection
Bottom Line
View on ClinicalTrials.gov: NCT00735072 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcome: Primary: Week 24 Change in Percentage of CD8+ T Cells That Co-express CD38 and HLA DR (Week 24 %CD38+HLA-DR+ CD8+ T Cells Minus Baseline %CD38+HLA-DR+ CD8+ T Cells) — 2.2; -0.7 %CD38+ HLA-DR+ CD8+ T cells — p=0.014
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Placebo (Drug); Maraviroc (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Week 24 Change in Percentage of CD8+ T Cells That Co-express CD38 and HLA DR (Week 24 %CD38+HLA-DR+ CD8+ T Cells Minus Baseline %CD38+HLA-DR+ CD8+ T Cells) |
2.2; -0.7 | 0.014 sig |
| SECONDARY Change in CD4+ T Cell Count |
17; 17 | 0.97 |
| SECONDARY Change in Ultra-sensitive Plasma HIV RNA Level (Single Copy/ml Assay) |
-52; -48 | 0.33 |
| SECONDARY Change in Brachial Artery Flow-mediated Dilatation (UCSF Site Only) |
1.0; 0.3 | — |
| SECONDARY Change in Gut-associated Lymphoid Tissue HIV RNA Level (UCSF Site Only) |
-11; -3 | — |
Summary
Many people with HIV fail to regain normal CD4 counts despite effectively suppressing HIV replication with medications. Blocking the "co-receptor" for HIV might decrease inflammation of the immune system, potentially providing an immune benefit. The goal of the current trial is to determine whether adding maraviroc, a new CCR5 "co-receptor" blocker, decreases inflammation, providing an immune benefit for patients with low CD4 counts despite undetectable viral loads on HIV medications.
In this study, HIV-infected patients who are receiving antiretroviral therapy for HIV will receive either maraviroc or a placebo (sugar pill) each day for 24 weeks. After 24 weeks, the study medication will be stopped and all subjects will be followed for 12 more weeks. Blood tests measuring the extent of inflammation, low-level viremia, and immune function will be measured throughout the trial and compared between treatment arms.
Eligibility Criteria
Inclusion Criteria
- HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.
- Stable antiretroviral therapy for at least 12 months
- Screening CD4+ T cell count below 350 cells/mm3
- All available CD4+ T cell counts in the last year and at screening 90% adherence to therapy within the preceding 30 days, as determined by self-report.
- Both male and female subjects are eligible. Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.
- Ability and willingness of subject or legal guardian/representative to provide informed consent
Exclusion Criteria
- Increase in CD4 count of > 100 cells/mm3 in past year.
- Patients who are intending to modify antiretroviral therapy in the next 24 weeks for any reason.
- Serious illness requiring hospitalization or parental antibiotics within preceding 3 months.
- Concurrent treatment with immunomodulatory drugs, or exposure to any immunomodulatory drug in past 16 weeks.
- HBVsAg+ or active hepatitis C or hepatitis B which will require treatment in the subsequent 24 weeks.
- Prior exposure to CCR5 inhibitors
- Screening absolute neutrophil count <1, 000 cells/mm3, platelet count <50,000 cells/mm3, hemoglobin < 8mg/dL, estimated creatinine clearance <40 mL/minute.
- Pregnant or breastfeeding women
- Use of both Tenofovir and Didanosine in current antiretroviral therapy regimen.
Data sourced from ClinicalTrials.gov (NCT00735072). 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.