Maraviroc switch study

Phase 1

• Conditions: Chronic HIV-1 Infection; MedDRA version: 16.0 Level: LLT Classification code 10008919 Term: Chronic HIV infection System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-002107-15-GB
• Lead Sponsor: niversity of New South Wales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-13
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 380

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.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 544
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

1. CXCR4 or CCR5/CXCR4 dual tropic HIV tropism or a nonreportable 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/µL
b. haemoglobin <8.0 g/dL
c. platelet count <50,000 cells/µL
d. serum AST, ALT >5 x upper limit of normal (ULN)
4. Active hepatitis B coinfection
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 clinical trial of medicinal product
• Study Design: Not specified