Human Immunodeficiency Virus (HIV-1) infection MedDRA version: 8.1 Level: PT Classification code 10020161 Term: HIV infection
Conditions
Interventions
Trade Name: Truvada
Product Name: Truvada
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: tenofovir disoproxil fumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Conce
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). •Available genotype (current or historical) showing M184V and (= 2 TAMs or K65R) •CD4 cell count =350 cells/mL •Patient request to stop HAART due to any of the following: 1) Patient is receiving a suppressive HAART regimen but has problems with adherence, quality of life or toxicity AND there is no alternative simpler, less toxic regimen (typically patients with substantial resistance and good virological control while receiving multiple antiretrovirals). 2) Due to resistance, patient is receiving a non-suppressive HAART regimen but patient is not willing to change to a new, already available, more complicated optimized salvage regimen (typically 3rd or 4th line of therapy). •For women of childbearing potential, negative urine pregnancy test at screening visit. •Agreement to take part in the study and sign the informed consent. Are the trial subjects under 18? no 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Patients receiving a non-registered antiretroviral (ARV) drug. •Patients who have < 50 HIV-RNA copies/mL while receiving an NNRTI. •Serum HBsAg positive and patient is receiving an anti-HBV active nucleoside/nucleotide. •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 that in clinician opinion contraindicates participation in the study •Women who are pregnant or breast feeding or females 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 (should be stopped prior to enrollment) •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 compare the immunologic changes with different treatment approaches after HAART discontinuation.;Secondary Objective: •To assess the time-weighted average change from baseline through 24 and 48 weeks ( DAVG24 and DAVG48) for log10 plasma HIV-1 RNA for patients with plasma HIV-1 RNA >50 copies/mL at baseline •To assess the time-weighted average change from 4 weeks through 24 and 48 weeks ( DAVG24 and DAVG48) for log10 plasma HIV-1 RNA for patients with <50 copies/mL at baseline •To assess the proportion of patients with HIV RNA <400 and <50 copies/mL at 4 weeks for subjects with plasma HIV-1 RNA <50 copies/mL at baseline •To compare log10 plasma HIV-1 RNA at week 4 for patients with HIV-RNA < 50 copies/mL at baseline. •To monitor the safety profile of each arm, recording all adverse events that may appear during the study. •To define the new resistance profile 24 and 48 weeks after the HAART discontinuations. •To assess changes in patient quality of life ;Primary end point(s): To compare CD4 cell loses 24 weeks after HAART discontinuation | — |
Countries
Spain
Outcome results
None listed