Overview

Lopinavir/r Monotherapy Versus Abacavir/Lamivudine and Lopinavir/r for Limb Fat Recovery in Persons With Lipoatrophy

Status:
Completed
Trial end date:
2012-09-01
Target enrollment:
0
Participant gender:
All
Summary
The aim of this study is to evaluate the efficacy for the recovery of peripheral fat of lopinavir/ritonavir in monotherapy versus abacavir/lamivudine and lopinavir/ritonavir in subjects who developed lipoatrophy while receiving zidovudine plus lamivudine plus abacavir.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fundacion SEIMC-GESIDA
Collaborator:
Abbott
Treatments:
Abacavir
Lamivudine
Lopinavir
Ritonavir
Criteria
Inclusion Criteria:

- Confirmation of the willingness of the patient to participate in this study after
being informed on all the aspects of the trial that may influence their decision,
signing and dating the written informed consent form approved by the Ethics Committee.

- The patient is 18 years of age or older.

- (Documented) HIV-1 infection.

- Receiving treatment with ZDV+3TC+ABC (in continuous antiretroviral treatment, without
discontinuation periods, for the past 6 months).

- There is confirmation that during the 6 months prior to inclusion in the study the
viral burdens were below 50 copies/mL.

- A viral burden below 50 copies/mL no more than 30 days before starting the study.

- No previous history of virological failure while on antiretroviral treatment with
protease inhibitors (PIs). That is, they have never switched protease inhibitors for
suspected or documented virological failure. The changes in protease inhibitor due
solely to toxicity, simplification or optimization are acceptable.

- Clinical evidence of moderate to severe lipoatrophy (according to the case definition
as scoring >- 2. For inclusion in the study, the subject should have moderate to
severe lipoatrophy in at least one site, and defined by the physician.

- Absence of signs of acute disease.

- Patient has not been treated for an active opportunistic infection within the 30 days
prior to the baseline visit.

- Patient with Karnofsky index >- 70.

- During the study, the patient does not require and agrees not to take any of the
following drugs that are contraindicated with LPV/r: astemizole, terfenadine,
midazolam, triazolam, cisapride, certain ergot derivatives (ergotamine,
dihydroergotamine, ergonovine, methylergonovine), pimozide, propafenone, and
flecainide. Rifampin, a potent enzyme inducer, should not be administered with the
study medication due to the possibility of a significant decrease in LPV/r
concentrations during concomitant administration, nor drugs contraindicated with 3TC
and ABC that in principle should not be being taken, as they are part of the treatment
at the screening.

- Patient agrees not to take any medication, including over-the-counter medicines,
alcohol, drugs, or herbal preparations without the knowledge and approval of the
principal investigator.

- Laboratory tests have been performed on the patients in the past 30 days:

- G/dL hemoglobin >8.0

- Absolute neutrophil count 750 cells/microl

- Platelet count 20,000/microl

- ALT or AST <5 x upper normal limit (UNL)

- Creatinine <1. 5 x UNL

- Triglycerides <750 mg/dL.

- For women, a negative result of a pregnancy test is available and they agree to use
throughout the study a barrier contraceptive method of proven reliability in the
investigator's opinion.

Exclusion Criteria:

- Patients with a history of virological failure on treatment with PIs; that is, that
they have at some point switched to PIs for confirmed or documented virological
failure.

- Patients with positive serum hepatitis B surface antigen.

- Patients requiring treatment with drugs where combination with LPV/r is
contraindicated.

- Presence of active opportunistic disease or wasting syndrome or under antitumoral
treatment with chemotherapy.

- Patients treated in the previous 16 weeks with agents susceptible to insulin
(glitazones or metformin), anabolic steroids, growth hormone or any agent that could
interfere with the study drugs.

- Active drug addiction or psychiatric disease that may prevent protocol compliance. Use
of cannabis or being on methadone treatment are excepted, provided protocol compliance
is not compromised in the investigator's opinion.

- Pregnant women or nursing mothers, and women of childbearing age if they do not agree
to use a barrier contraceptive method throughout the study of proven reliability in
the investigator's opinion.

- In the opinion of the principal investigator, the patient is unlikely to comply with
the study protocol, or the patient is not eligible for any other reason.