Switching from regimens consisting of a RTV -boosted protease inhibitor plus TDF/ FTC to a combination of RAltegravir pluis NevIrapine and IAmivudine in HIV patients with suppressed viremia and and impaired renal function (RANIA study)

Phase 1

• Conditions: Each subject must be ? 18 years of age with a diagnosis of HIV Infections; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2013-001637-40-IT
• Lead Sponsor: MSD Italia s.r.l

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-31
• Study Completion: 2017-07-10
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 11

Inclusion Criteria

1. Each subject must be ? 18 years of age.
2. Each subject must be male or non-pregnant, non-breastfeeding female
3. Each subject must have diagnosis of HIV infection.
4. Each subject must have no history of previous virological failure (defined as 2 consecutive plasma HIV-1 RNA >200 copies/mL while on previous or current ARV therapy)
5. Each subject must have no history of previous exposure to NNRTIs or INIs prior to entering the study
6. Each subject must have no history of previous intolerance to Lamivudine
7. Each subject must have at least 2 documented plasma HIV-1 RNA <50 copies/mL and no HIV-1 RNA >50 copies/mL in the 12 months prior to the screening visit
8. Each subject must be taking the same PI/r + TDF/FTC based ARV combination for at least 6 months before screening
9. Each subject mustn't have major IAS-USA mutations on genotypic testing performed before starting ARV treatment.
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 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1.The subject has HBsAg+ or anticipated need for HCV-treatment
2. The subject has grade 2-4 laboratory abnormality of liver transaminases (ALT and AST)
3. The subject has experiencing liver cirrhosis
4. The subject has an allergy/sensitivity to investigational product or its/their excipients.
5. The female subject is nursing.
6. The female subject is pregnant or intending to become pregnant.
7. The subject has any clinically significant condition or situation, other than the condition being studied that,
in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the
trial.
8. The subject has active AIDS-defining event (CDC-C), exception for stable Kaposi Sarcoma, HIV Wasting
Syndrome.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified