Analysis of C-C chemokine receptor type 5 antagonist, as an add-on treatment for HIV-1 patients with virological response but no immunological response: a pilot study

Analysis of C-C chemokine receptor type 5 antagonist, as an add-on treatment for HIV-1 patients with virological response but no immunological response: a pilot study - Analysis of C-C chemokine receptor type 5 antagonist, as an add-on treatment for HIV-1 patients with virological response but no immunological response

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008746

Enrollment

Registered

2012-08-21

Start date

2011-10-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1 infection

Interventions

Maraviroc (150-300mg twice daily), as an add-on treatment to optimized background anti-retroviral therapy in treatment-experienced patients.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with HIV-1 infection 2. Age > 20 years old 3. Patients who have received > 3 classes of anti-HIV drugs for more than 48 weeks 4. Patients who were not changed anti-retroviral therapy regimen for more than 24 weeks 5. Patients with a CD4+ T cell count < 350 cells/microL 6. Patients who were not experienced a CCR5 antagonist treatment 7. No pregnat and lactating woman 8. Completed the written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients who could be changed anti-retroviral therapy regimen during the research 2. Patients with hypersensivity to CCR5 antagonist 3. Patients with severe underlyng heart diseases 4. Patients with liver cirrhosis or liver dysfunction: AST or ALT > 3 upper limit of normality 5. Patients with renal dysfunction: eGFR<60mL/min/1.73m2 6. Patients with neutrophil< 1,000/microL, hemoglobin<10g/dL, or platelet< 100,000/microL 7. Patients with severe infectious diseases such as mycobacterium infection, deep fungal infection, cytomegalovirus infection

Design outcomes

Primary

Measure	Time frame
The changes of CD4+ T cell count from baseline to 24, 48 and 96 weeks.	—

Countries

Japan

Contacts

Public ContactMasayuki Murata

Kyushu-University Hospital Department of General internal medicine

mmurata@gim.med.kyushu-u.ac.jp092-642-5909

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026