Phase 4
Completed N=40
Atazanavir and Lamivudine for Treatment Simplification
Source: ClinicalTrials.gov NCT00885482 ↗Enrolled (actual)
40
Serious AEs
15.0%
Results posted
Feb 2015
Primary outcomePrimary: Number of Patients With Virological Failure (Two Consecutive Measures of HIV-RNA Higher Than 50 Copies/mL or a Single Measure Higher Than 1000 Copies/mL) Within 48 Weeks at intention-to.Treat Analysis — 1 patients
Summary
Objectives of the study:
1. To verify the safety of the study treatment, defined as the persistent control of the virus' replication at 48 weeks after the simplification to lamivudine + atazanavir with ritonavir.
2. To collect relevant information about the safety and the metabolic impact of this strategy in order to eventually design a non-inferiority randomized controlled trial for the evaluation of the safety and the efficacy of this strategy in the future.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Virological Failure (Two Consecutive Measures of HIV-RNA Higher Than 50 Copies/mL or a Single Measure Higher Than 1000 Copies/mL) Within 48 Weeks at intention-to.Treat Analysis |
1 | — |
| SECONDARY Time to Virological Failure at Survival Analysis |
— | — |
| SECONDARY Number of Patients With Viral Load Lower Than 50 Copies/mL at 48 Weeks at the Intention to Treat Analysis |
— | — |
| SECONDARY Evolution of CD4 Cell Count During the 48 Weeks |
— | — |
| SECONDARY Evolution of Adherence and Quality of Life During the 48 Weeks |
— | — |
| SECONDARY Evolution of Atazanavir Plasma Concentrations During the 48 Weeks |
— | — |
| SECONDARY Change of Metabolic Parameters at 48 Weeks |
— | — |
| SECONDARY Change of the Results of Neurocognitive Tests at 48 Weeks |
— | — |
| SECONDARY Change of Bone Density and of Subcutaneous Fat at 48 Weeks |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patients treated with the same regimen including 2NRTIs + ATV/r from at least 6 months
- Aged 18 years or older
- Who gave informed consent to the participation to the study
- With at least two viral load 200 cells/μL and absence of any opportunistic infection or AIDS-related disease by one year at least
Exclusion Criteria
- Pregnancy or breast feeding, desire of pregnancy in the short term
- Previous virological failure to antiretroviral therapy and/or previous exposure to mono- or dual therapies with reverse transcriptase nucleosidic analogues
- Patients with insufficient atazanavir plasma through concentration (lower than 0.23 μg/mL at 12th hour or 0.15 μg/mL at 24th hour) at screening and/or at baseline
- Patients with grade 3 or 4 laboratory abnormalities at screening (except for glucose or lipid serum levels and direct or indirect bilirubin)
- Concomitant treatment with antacids or proton-pump blockers or any other drug with known interactions or contraindications with the study medications
Data sourced from ClinicalTrials.gov (NCT00885482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.