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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000496-64-ES

Enrollment

Registered

2014-03-03

Start date

2014-04-23

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1 infection

Interventions

Trade Name: REYATAZ Pharmaceutical Form: INN or Proposed INN: ATAZANAVIR SULFATE Current Sponsor code: ATAZANAVIR SULFATE Other descript

Eligibility

Sex/Gender

Male

Inclusion criteria

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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
Secondary end point(s): Atazanavir concentrations in CSF;Timepoint(s) of evaluation of this end point: 3 months	—

Countries

Spain

Contacts

Public ContactDr. Arkaitz Imaz

Hospital Universitari de Bellvitge

aimaz@bellvitgehospital.cat0034932267667

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026