A randomised, open-label study to evaluate the efficacy and safety of maraviroc (MVC) as a switch for either nucleoside or nucleotide analogue reverse transcriptase inhibitors (N(t)RTI) or boosted protease inhibitors (PI/r) in HIV-1 infected individuals with stable, well-controlled plasma HIV-RNA while taking their first N(t)RTI + PI/r regimen of combination antiretroviral therapy (cART): MARCH study

Phase 4

Recruiting

• Conditions: HIV; Inflammatory and Immune System - Other inflammatory or immune system disorders; Infection - Acquired immune deficiency syndrome (AIDS / HIV)

• Registration Number: ACTRN12611000816954
• Lead Sponsor: niversity of New South Wales, Kirby Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 560

Inclusion Criteria

1. Documented HIV-1 infection by a licensed diagnostic test at any time prior to study entry
2. Age >18 years
3. HIV-1 RNA <200 copies/mL plasma for at least 24 weeks
4. Stable (>24 weeks) ART including two N(t)RTIs and a PI/r
5. No evidence of any primary HIV genotypic mutations in HIV reverse transcriptase or protease for all patients with available resistance testing results conducted prior to cART and/or during viral rebound/failure
6. Provision of written, informed consent.

Exclusion Criteria

1. CXCR4 or CCR5/CXCR4 dual tropic HIV tropism or a non-reportable tropism result based on assessment using proviral DNA
2. Anticipated need to modify current cART regimen for toxicity management in the next 6 months
3. The following laboratory criteria,
a. absolute neutrophil count (ANC) <750 cells/micro L
b. haemoglobin <8.0 g/dL
c. platelet count <50,000 cells/micro L
d. serum AST, ALT >5 x upper limit of normal (ULN)
4. Active hepatitis B co-infection
5. Pregnant women or nursing mothers
6. Current use of any prohibited medications as described in product specific information.
7. Hypersensitivity to soy or peanuts
8. Acute therapy for serious infection or other serious medical illness (in the judgement of the site Principal Investigator) requiring systemic treatment and/or hospitalisation
9. Use of immunomodulators (e.g. systemic corticosteroids, recombinant interleukin-2, interferon) within 30 days prior to screening
10. Patients with current alcohol or illicit substance use that in the opinion of the site Principal Investigator would conflict with any aspect of the conduct of the study
11. Patients unlikely to be able to remain in follow-up for the protocol-defined period
12. Prisoners or subjects who are compulsorily detained (involuntary incarcerated).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The comparison of the switch arms to control arm of proportions of participants with HIV RNA <200 copies/mL[48 weeks after randomization]