Phase 2
N=13
Effects of Maraviroc (MVC) on HIV-related Kaposi's Sarcoma (KS)
Kaposi's Sarcoma
Bottom Line
View on ClinicalTrials.gov: NCT01276236 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Number of Participants With a Decrease in Kaposi's Sarcoma (KS) Total Surface Area — 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Maraviroc (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Decrease in Kaposi's Sarcoma (KS) Total Surface Area |
11 | — |
| PRIMARY Percent Change in KS Total Surface Area |
-28.1 | — |
| PRIMARY Change in Edema Grade |
-0.7 | — |
| SECONDARY Change in Kaposi's Sarcoma-associated Herpesvirus (KSHV) Viral Load |
— | — |
| SECONDARY Percent Change in CCR5 Levels on CD4+ T-Cells |
22.8 | — |
| SECONDARY Percent Change in CCR5 Levels on CD8+ T-cells |
21.6 | — |
| SECONDARY Percent Change in CD69 Expression in a Subset of Double Negative DR-CD38 Positive (DR-CD38+) T-cells |
89.7 | — |
| SECONDARY Percent Change in CD69 Expression in a Subset of Double Negative DR-CD38 Negative (DR-CD38-) T-cells |
50.5 | — |
Summary
The purpose of this pilot study is to determine whether Maraviroc is effective in the treatment of Kaposi's Sarcoma (KS), when it does not remit with standard antiretroviral drug therapy.
Eligibility Criteria
Inclusion Criteria
- HIV-1 infected, 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.
- Active biopsy confirmed KS
- Screening plasma HIV RNA 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
- 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 therapies, or exposure to any immunomodulatory drug or therapy in past 16 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.
- Elevated transaminases greater than 2.5 times the upper limit of normal.
- Evidence of cirrhosis
- Pregnant or breastfeeding women
- Use of both Tenofovir and Didanosine in current antiretroviral therapy regimen.
- Local therapy for any KS index lesion in preceding 60 days, unless lesion has clearly progressed with enlargement since the local therapy
Data sourced from ClinicalTrials.gov (NCT01276236). 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.