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Prevention of Lipoatrophy in Patients Treated With Lopinavir/Ritonavir in Monotherapy Versus ZDV + 3TC + ABC

Information source: Fundacion SEIMC-GESIDA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infection; HIV Infections

Intervention: AZT+3TC+ABV (Trizivir) (Drug); Switching to LPV/r monotherapy (Kaletra) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Fundacion SEIMC-GESIDA

Official(s) and/or principal investigator(s):
Jose Antonio Iribarren, Study Chair, Affiliation: Hospital de Donostia

Summary

The aim of this study is to measure the prevention of lipoatrophy in patients treated with Lopinavir/R in monotherapy versus ZDV + 3TC + ABC

Clinical Details

Official title: A Randomized Comparative Clinical Trial of ZDV + 3TC + ABC (Trizivir) vs Monotherapy With Lopinavir/R (Kaletra) in Patients With Viral Suppression on Previous Treatment With ZDV + 3TC + ABC (Trizivir) for Preventing Lipoatrophy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Limb Fat changes measured by DEXA

Secondary outcome:

20 % loss peripheral fat measured by DEXA

Perception of change on body fat by physician and patient.

Lipohypertrophy

Detailed description: In recent years mayor progress has been made in therapeutic approaches with the introduction of HAART, which has meant a huge fall in morbidity-mortality in Western countries. However, despite having a variety of potent HAART combinations, some patients do not obtain adequate suppression. The causes of virological failure are complex, and one of the most significant factors is the incomplete compliance with the prescribed dosage of highly-active antiretroviral therapy (HAART). The development of fixed dose combination products is most commonly used to help simplify the dosages and improve treatment compliance. One of the main problems associated with the treatment of HIV infection is the change in body structure, generally grouped under the term of lipodystrophy. These usually include fat accumulation in the stomach, or abdominal girth, and, even worse, atrophy in the face, arms, and legs. It is usually associated with metabolic disorders, with increased levels of triglycerides, cholesterol and/or insulin resistance. The incidence of lipodystrophy increases progressively over time in patients starting treatment with antiretroviral agents. It is estimated that, after 2 years of treatment, 20%-30% of patients experience moderate or severe lipodystrophy. Trizivir® is a combination of three antiretroviral agents: Abacavir, Lamivudine and Zidovudine in a tablet. All of them belong to the group of nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs. The main advantage of Trizivir is the possibility of simplifying antiretroviral treatment. Multiple studies have been performed showing that simplification of HAART with Trizivir enhances compliance and improves quality of life in patients maintaining the efficacy of previous antiretroviral treatments. Kaletra® (lopinavir+ritonavir) is a combination of two protease inhibitors: lopinavir plus a low dose of ritonavir, enhancing the action of the former. Previous studies have shown that most patients treated with Kaletra monotherapy have an undetectable viral load after 48 weeks. Monotherapy failures were not associated with the development of primary resistance mutations. To date the development of lipoatrophy appears to occur more frequently in patients with a NRTI- containing regimen. The combination of abacavir, zidovudine and lamivudine has been investigated in patients naive to antiretroviral treatments and in patients already treated with NRTIs. In this setting, we designed this clinical trial to establish the potential benefit of Kaletra in monotherapy for the prevention of lipoatrophy. For this purpose, we will compare keeping on treatment with TZV in patients with viral suppression vs switching to Kaletra in monotherapy in order to prevent fat changes. Since the purpose of the study is to establish the ability of Kaletra to prevent the development of and exclude patients with acute intolerance to Kaletra, the patients assigned to the experimental group will be treated for 4 weeks with Trizivir and Kaletra before switching to Kaletra monotherapy.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients infected with HIV 1 documented by positive HIV 1 antibody test and/or

positive PCR test confirmed for HIV 1 RNA.

- Patients on treatment with Trizivir with an undetectable viral burden defined as < 50

copies/ml in the past 6 months.

- Men or women aged ≥ 18 years.

- CD4 cell count ≥ 200 cells/μl.

- For women of child bearing age, a negative urine pregnancy test at the screening

visit.

- Patients giving their written informed consent before completing any study specific

screening procedure. Exclusion Criteria:

- Patients with previously failed therapy with protease inhibitors (PI) or those

receiving sub optimum therapy with nucleoside analogue reverse transcriptase inhibitors (NRTI) for the study disease.

- Presence of lipoatrophy defined by the investigator (any grade) or by the patient (in

this case, at least two sites of mild degree or one of at least moderate degree).

- Known history of drug addiction or chronic use of alcohol that, in the investigator's

opinion, contraindicates participation in the study.

- Pregnant or nursing women or women of child bearing age not using an adequate

contraceptive method according to the investigator's criterion.

- Current active opportunistic infection or documented infection in the 4 weeks prior

to screening.

- Renal disease with creatinine clearance < 50 ml/min.

- Concomitant use of nephrotoxic or immunosuppressive agents.

- Patient currently treated with systemic corticosteroids, interleukine 2, or

chemotherapy.

- Patients treated with other investigational agents.

- Patients with acute hepatitis.

- Any disease that, at the criterion in the investigator, contraindicates the patient's

participation in the study.

Locations and Contacts

Hospital Doce de Octubre, Madrid 28041, Spain

Hospital La Paz, Madrid 28046, Spain

H. Son Dureta, Mallorca, Spain

Hospital Ntra.Sra. de Zumarraga, Zumarraga, Guipuzcua 28700, Spain

Hospital Severo Ochoa, Leganes, Madrid 28911, Spain

Hospital de Donostia, Donostia, San Sebastian 20014, Spain

Hospital de Basurto, Bilbao, Vizcaya 48013, Spain

Additional Information

Starting date: December 2008
Last updated: September 11, 2013

Page last updated: August 23, 2015

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