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

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion SEIMC-GESIDA
• Collaborator: Abbott
• Treatments: Lopinavir

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.