PRotease-Inhibitors MOnotherapy Strategies as maintenance therapy in persons with fully suppressed HIV replication: results from an open-label randomized comparative trial (PRIMO Trial) - PRIMO Trial

Conditions: HIV infection
MedDRA version: 12.0Level: LLTClassification code 10008919Term: Chronic HIV infection

Registration Number: EUCTR2009-016697-32-IT

Lead Sponsor: ISTITUTO NAZIONALE DELLE MALATTIE INFETTIVE LAZZARO SPALLANZANI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

At least 18 years; Receiving unchanged HAART regimen including two NRTIs and PI/boosted for at least 24 weeks; Plasma HIV-RNA <40 copies/mL for at least 48 weeks prior the screening (two results must be documented); Nadir CD4 >100 cell/mmc, and CD4>200 cell/mmc at screening. No previous history of suspected or confirmed virological failure while receiving a protease inhibitor; Signed and dated written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

History of virological failure defined as two consecutive plasma HIV-RNA >50 cp/ml while on previous or current antiretroviral therapy History of any primary PI mutations as defined by the IAS-USA guidelines 2008 Clinical or laboratory evidence of significantly decreased hepatic function or decompensation Diagnosis of acute viral hepatitis at screening Pregnant or breastfeeding woman Acute opportunistic infection requiring treatment (exclusion period: 30 days) Mycobacteriosis under treatment Malignancy requiring chemotherapy or radiotherapy Positive HBsAg HCV infection for which specific treatment is ongoing or planned during the first year on trial treatment. Contraindicated concomitant treatment Previous history of intolerance to LPV/r or DRV/RTV leading to treatment discontinuation Participation in another clinical trial with an on-going exclusion period at screening Subjects which in the opinion of the investigator is unable to complete the study period.