null - FindTrial

A RANDOMISED OPEN-LABEL STUDY COMPARING THE SAFETY AND EFFICACY OF RITONAVIR BOOSTED LOPINAVIR AND 2-3N(T)RTI BACKBONE VERSUS RITONAVIR BOOSTED LOPINAVIR AND RALTEGRAVIR IN PARTICIPANTS VIROLOGICALLY FAILING FIRST-LINE NNRTI/2N(T)RTI THERAPY. SECOND LINE STUDY.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-007-10

Enrollment

Registered

2010-03-31

Start date

2010-08-26

Completion date

Unknown

Last updated

2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Treatment arms: -Brazo I (Control Regime): ritonavir-boosted lopinavir (LPV / r) 200mg / 50mg, 4 tablets 1time / day or 2 tablets 2times / day + 2-3N (t) RTIs, orally. -Brazo II (experimental re

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. HIV-1 positive by diagnostic testing license 2. adults aged 16 years or older (or age as determined by local regulations or legal requirements dictate) 3. Having received the first antiretroviral regimen consisting of an NNRTI plus 2 N (t) RTIs = 24 weeks 4. No change in antiretroviral therapy in the previous 12 weeks selection 5. first line NNRTI + 2 n (t) RTI combination therapy in Failed function virologic criteria defined by two consecutive (= 7 days apart) results HIV RNA> 500 copies / ml 6. No previous or current inhibitors of HIV protease and / or inhibitors of HIV integrase exposure 7. able to provide written informed consent of trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (> = 65 years) no F.1.3.1 number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. The following laboratory variables: a) absolute neutrophil count (ANC) 5xULN 2?? . pregnant women or nursing 3. patients with active viral infection hepatitis B defined by the presence in the serum of hepatitis B surface antigen 4. the use of immunomodulators within 30 days prior to use selection 5. of any prohibited drug (rifampicin, midazolam, triazolam, cisapride, pimozide, amiodarone, dihydroergotamine, ergotamine, ergonovine, methylergonovine, astemizole, terfenadine, vardenafil, and St. John´s wort) 6. intercurrent illness requiring hospitalization 7. opportunistic disease active that they are not under proper control in the opinion of the principal investigator site 8. patients with current alcohol or substance abuse, in opinion of the principal investigator site could adversely affect participation in the study 9 patients in the opinion of the principal investigator site unlikely to be able to stay on track for period defined by the protocol

Contacts

Public ContactCarlos Rafael Seas

CONSULTORES EN INFECTOLOGIA S.A.C.

cseas2@gmail.com986602282

Outcome results