Human Immunodeficiency Virus (HIV-1) infection MedDRA version: 8.1 Level: PT Classification code 10020161
Conditions
Interventions
Product Name: Truvada
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Emtricitabina
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
INN or Propos
Sponsors
Gilead Sciences S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • HIV-1 infection documented by confirmed positive HIV-1 antibody test and/or positive PCR for HIV-1 RNA. • Adult patients (over 18 years of age). • Current HAART regimen containing AZT + 3TC at usual doses for at least during the previous 6 months. • Viral load =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients on current TDF or FTC therapy. • Patients with previous history of virological failure on FTC or TDF containing regimen. • Patients receiving a non-registered antiretroviral (ARV) drug. • Patients receiving a triple nucleoside-ARV combination. • Hypersensitivity to one of the components of the dosage forms of TDF or FTC, or previous history of intolerance to one of these drugs. • Known history of drug abuse or chronic alcohol consumption • Women who are pregnant of breast feeding or female of childbearing potential who do not use an adequate method of contraception according to the investigator’s judgment. • Current active opportunistic infection or documented infection within the previous 4 weeks. • Documented active malignant disease (excluding Kaposi sarcoma limited to the skin). • Renal disease with creatinine clearance < 50 mL/min. • Concomitant use of nephrotoxic or immuno-suppressive drugs which could not be stopped without affecting the safety of the patient. • Receiving on-going therapy with systemic corticosteroids, Interleukin-2 (IL-2) or chemotherapy. • Patients who are not to be included in the study according to the investigator’s criterion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore changes in limb fat assessed by DEXA measurements, after the substitution of the Zidovudine + Lamivudine NRTI-backbone by Truvada (TDF+FTC) versus maintaining the original Zidovudine-containing regimen without any change, through 48 wk.;Primary end point(s): Objective assessment: of change from baseline in limb fat at Week 48 as measured by DEXA.;Secondary Objective: • To explore changes in the mtDNA/nDNA ratio in PBMC in each study group. • To assess the proportion of patients with HIV RNA < 400 and < 50 copies/mL during the follow-up weeks (weeks 12-72) in each group. • To assess changes in CD4+ cell count in each group throughout the study. • To monitor the safety profile of both treatment arms, recording all adverse events that may appear during the study. • To define the resistance profile in case of virological failure. • To assess the changes in hemoglobin and hematocrit levels in each group. • To assess metabolic parameters in each group (total cholesterol, HDLc, LDLc, triglycerides, lactic acid). • To assess patient adherence | — |
Countries
Spain
Outcome results
None listed