Status:
COMPLETED
Prevention of Lipoatrophy in Patients Treated With Lopinavir/Ritonavir in Monotherapy Versus ZDV + 3TC + ABC
Lead Sponsor:
Fundacion SEIMC-GESIDA
Collaborating Sponsors:
Abbott
Conditions:
HIV Infection
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00865475
Start Date
December 1 2008
End Date
March 1 2013
Last Update
September 12 2013
Active Locations (7)
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1
Hospital Ntra.Sra. de Zumarraga
Zumarraga, Guipuzcua, Spain, 28700
2
Hospital Severo Ochoa
Leganés, Madrid, Spain, 28911
3
Hospital Doce de Octubre
Madrid, Madrid, Spain, 28041
4
Hospital La Paz
Madrid, Madrid, Spain, 28046