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

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Servizio Regionale di Immunologia Clinica e Tipizzazione Tissutale, Azienda Ospedaliero-Universitaria, Torrette Di Ancona, AN, Italy

About this study

Objectives:

Evaluate the clinical efficacy of HAART intensification with MVC as treatment of HIV-1 infection in patients with a CD4 count ≤ 200 cells/uL and/or a recovery of CD4 cells < 25% compared to the HAART initiation and with a complete and stable virologic suppression after 12 months of HAART. Patients could also being included if their CD4 slope has been stable without any improvement, with an absolute value around 200 cells/uL.
Evaluate the effects of HAART intensification with MVC on the modification of immunologic and virologic parameters.
Evaluate the tolerability of HAART intensification with MVC and the appearance of drug-related side effects.

Design:

This will be a randomised, multicenter, study that will evaluate HAART intensification with MVC as treatment of HIV-1 infection in patients with a CD4 count ≤ 200 cells/uL and/or a recovery of CD4 cells < 25% compared to the HAART initiation and/or a stable CD4 slope without any improvement, with an absolute value around 200 cells/uL and with a complete and stable virologic suppression after 12 months of HAART.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Maraviroc

Drug

Maraviroc is administered BID according to the other drugs within HAART; dosage ranges from 150 mg to 600 mg bid.

Other names: Maraviroc brand name in the EC is Celsentri.

Primary outcomes

CD4 counts > 200/uL or recovery of CD4 > 25% in 2 consecutive time-points.

Time frame: 3 and 12 months

Sponsors and collaborators

Lead sponsor

ASST Fatebenefratelli Sacco

Other

Registry information

Official study title

Use of Maraviroc (MVC) in Immunological Non-responder HIV-1-infected Patients.

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Apr 21, 2009
Registry last updated: Apr 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed