Clinical trial · Interventional
Effects of Maraviroc (MVC) on HIV-related Kaposi's Sarcoma (KS)
NCT01276236CI-TRIAL-00050504completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kaposi's Sarcoma | Kaposi Sarcoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Maraviroc | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Arm (Maraviroc)
- description
- The subjects in this arm will receive Maraviroc as treatment, while continuing their current antiretroviral medication regimen.
- interventionNames
- Drug: Maraviroc
Primary outcomes (3)
- measure
- Number of Participants With a Decrease in Kaposi's Sarcoma (KS) Total Surface Area
- timeFrame
- Up to 96 weeks
- description
- To assess improvements in disease, up to five bi-dimensionally measurable cutaneous KS lesions were selected as marker lesions. The collective surface area of the marker lesions was evaluated over the course of the study for either an increase or decrease in the total surface area of lesions using the modified AIDS Clinical Trials Group (ACTG) Oncology Committee Staging Criteria.
- measure
- Percent Change in KS Total Surface Area
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 \< 75 copies/mL * Patients have unremitting KS. Unremitting is defined as having active biopsy confirmed KS in spite of having had sustained HIV RNA \< 75 copies/mL for 24 prior months. Isolated values that are detectable but \< 500 copies will be allowed as long as the plasma HIV RNA levels before and after this time point are undetectable. * \>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
References
Publications (20)
- BACKGROUNDEngels EA, Pfeiffer RM, Goedert JJ, Virgo P, McNeel TS, Scoppa SM, Biggar RJ; HIV/AIDS Cancer Match Study. Trends in cancer risk among people with AIDS in the United States 1980-2002. AIDS. 2006 Aug 1;20(12):1645-54. doi: 10.1097/01.aids.0000238411.75324.59. PMID 16868446
- BACKGROUNDParkin DM, Nambooze S, Wabwire-Mangen F, Wabinga HR. Changing cancer incidence in Kampala, Uganda, 1991-2006. Int J Cancer. 2010 Mar 1;126(5):1187-95. doi: 10.1002/ijc.24838. PMID 19688826
- BACKGROUNDGulick RM, Lalezari J, Goodrich J, Clumeck N, DeJesus E, Horban A, Nadler J, Clotet B, Karlsson A, Wohlfeiler M, Montana JB, McHale M, Sullivan J, Ridgway C, Felstead S, Dunne MW, van der Ryst E, Mayer H; MOTIVATE Study Teams. Maraviroc for previously treated patients with R5 HIV-1 infection. N Engl J Med. 2008 Oct 2;359(14):1429-41. doi: 10.1056/NEJMoa0803152. PMID 18832244
- BACKGROUNDNakano K, Isegawa Y, Zou P, Tadagaki K, Inagi R, Yamanishi K. Kaposi's sarcoma-associated herpesvirus (KSHV)-encoded vMIP-I and vMIP-II induce signal transduction and chemotaxis in monocytic cells. Arch Virol. 2003 May;148(5):871-90. doi: 10.1007/s00705-002-0971-7. PMID 12721796
- BACKGROUNDNavenot JM, Wang ZX, Trent JO, Murray JL, Hu QX, DeLeeuw L, Moore PS, Chang Y, Peiper SC. Molecular anatomy of CCR5 engagement by physiologic and viral chemokines and HIV-1 envelope glycoproteins: differences in primary structural requirements for RANTES, MIP-1 alpha, and vMIP-II Binding. J Mol Biol. 2001 Nov 9;313(5):1181-93. doi: 10.1006/jmbi.2001.5086. PMID 11700073
- BACKGROUNDShao W, Fernandez E, Sachpatzidis A, Wilken J, Thompson DA, Schweitzer BI, Lolis E. CCR2 and CCR5 receptor-binding properties of herpesvirus-8 vMIP-II based on sequence analysis and its solution structure. Eur J Biochem. 2001 May;268(10):2948-59. doi: 10.1046/j.1432-1327.2001.02184.x. PMID 11358512