Atazanavir and Lamivudine for Treatment Simplification

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-05-31

Brief Summary

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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.

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Detailed Description

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Combined antiretroviral therapy has greatly improved the natural history of HIV infection/AIDS. Yet, it is associated with important short- and long- term side effects. In particular, nucleoside and nucleotide analogs may cause anemia, pancreatitis, mitochondrial dysfunction, lactic acidosis, lipoatrophy and reduction of renal function or of bone density.

Our study aims to verify the safety and efficacy of a simplification of a dual therapy (Lamivudine plus Atazanavir with Ritonavir), confiding on the potency and high genetic barrier of ritonavir-boosted agents.

Conditions

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HIV Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single arm

Treatment simplification from a "standard" combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy.

Group Type EXPERIMENTAL

Lamiduvine (Epivir)

Intervention Type DRUG

Epivir 300 mg

Atazanavir (Reyataz)

Intervention Type DRUG

Reyataz 300 mg

Ritonavir (Norvir)

Intervention Type DRUG

Norvir 100 mg

Interventions

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Lamiduvine (Epivir)

Epivir 300 mg

Intervention Type DRUG

Atazanavir (Reyataz)

Reyataz 300 mg

Intervention Type DRUG

Ritonavir (Norvir)

Norvir 100 mg

Intervention Type DRUG

Eligibility Criteria

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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 \< 50 copies/mL in two consecutive determinations at least 3 months apart
* With CD4 cell count \> 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No