Viral suppression in Cerebrospinal Fluid in HIV-1 infected patients receiving Ritonavir-boosted Atazanavir plus lamivudine dual theraphy. SCALA study

Phase 1

• Conditions: HIV-1 infection; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-000496-64-ES
• Lead Sponsor: Dr. Daniel Podzamczer Palter. Hospital Univesitari de Bellvitge. Unidad de VIH.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-03
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1. HIV-1 infected men = 18 years of age.
2. Chronic HIV-1 infection
3. Be on a stable ART consisting of tenofovir/emtricitabine plus ritonavir-boosted atazanavir, continously for at least 1 month before the screening visit.
4. HIV-1 RNA <40 c/mL for at least 6 months before the Screening visit.
5. Signed and dated written informed consent prior to inclusion.
6. Subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse from the screening visit throught the duration of the study.

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 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Severe hepatic insufficiency (Child-Pugh Class C)
2. Chronic infection with hepatitis B virus (HBV)
2. Ongoing malignancy
3. Active opportunistic infection
.4. Primary resistance to any of the ARV included in the study (genotypes without evidence of lamivudine resistance (mutation M184V/I) and mutations protease inhibitors resistance-associated mutations (IAS USA list) or history of virologic failure with risk of resistance selection to any of the study drugs.
5. Any verified Grade 4 laboratory abnormality.
6. ALT or AST = 3xULN and/or bilirubin = 1.5xULN.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine HIV-1 RNA in CSF in HIV-1 infected subjects receiving treatment with Atazanavir 300 mg boosted with Ritonavir 100 mg plus lamivudine 300 mg;Secondary Objective: To determine atazanavir concentrations in CSF;Primary end point(s): HIV-1 RNA in CSF >3 months after switching from tenofovir/emtricitabine plus atazanavir/r to lamivudine plus atazanavir/r.;Timepoint(s) of evaluation of this end point: 3 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Atazanavir concentrations in CSF;Timepoint(s) of evaluation of this end point: 3 months