Maraviroc in Immunological Non-Responder (INR) HIV-1-infected Subjects

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Suboptimal improvement in cluster of differentiation 4 (CD4) cell count is not uncommon in HIV-1-infected patients with suppressed plasma HIV-Ribonucleic acid (RNA) levels, and a decrease in CD4 cell count in patients with suppressed or low level viremia has been observed.

Although the efficacy of current antiretroviral medications is well established, some antiviral combinations are very effective in suppressing HIV-1 load whereas do not exert any effect on immune reconstitution.

Both T-cell immune activation and fibrosis of peripheral lymphoid tissue could create an environment in which CD4 T cell count decrease in the setting of low or suppressed plasma viremia is likely to occur.

Another fascinating hypothesis, which has still to be elucidated, is that reconstitution of the depleted CD4 pool is blocked by an excess of glycoprotein 120 (gp120) HIV-1 protein. This extra-production could be counteracted by an inhibitor of the chemokine (C-C motif) receptor 5 (CCR5) co-receptor that represents one of the major docking tools of HIV-1.

With this in mind, the investigators would like to propose and design a pilot exploratory clinical trial involving a population of HIV-1-infected patients that rapidly reached a virologic suppression without a reconstitution of their immune system.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ASST Fatebenefratelli Sacco; Ospedale L. Sacco – Polo Universitario
• Treatments: Maraviroc

Criteria

Inclusion Criteria:

• age > or = 18

• HIV-Abs positivity detected by ELISA and confirmed by Western-Blot

• CD4 lymphocytes < 200/uL and/or CD4 recovery < 25% after at least 12 months of stable HAART

• HIV-RNA < 50 cp/mL during the last 12 months

• negative pregnancy test at least 14 days prior to treatment

• understanding and signing the informed consent

Exclusion Criteria:

• allergy/intolerance to the study drug

• less than 1 year from any treatment with immunomodulatory agents

• current OIs or neoplasms

• current CVD or EKG abnormalities

• current respiratory tract diseases or COPD

• treatment with steroids within 4 weeks from treatment beginning

• suspect of autoimmune disorder or chronic inflammatory disease

• active IVDUs or alcohol addicts

• AST and ALT > 2.5 ULD

• serum creatinine > 1.5 ULD

• ANC < 1000/uL

• hemoglobin < 10 g/dL

• platelets < 75.000/uL

• reticulocytes > 2%

• Karnofsky score < 50