HIV-Infected Patients Evidencing Virologic Suppression Pacientes infectados de VIH, con supresión virológica evidente
Conditions
Interventions
Trade Name: Reyataz
Product Name: REYATAZ
Product Code: BMS-232632
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Atazanavir Sulfate
CAS Number: 229975-97-7
Current Sponsor code: BMS-232632-0
Sponsors
Bristol-Myers Squibb S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Provide written informed consent and is capable of reading and comprehending the informed consent 2) On continued antiretroviral treatment, with no discontinuation periods, for the previous 6 months. 3) Absence of evidence or suspected virological failure while receiving any previous antiretroviral therapy. 4) Absence of known primary mutations in the protease gene. 5) Subjects must have received only one HAART regimen prior to the current ATV one. Prior changes in the nucleoside backbone are allowed but subjects may not have experienced confirmed virological failure. In patients with prior NNRTI exposure, a well documented history ensuring no evidence of resistance development to that family is required. No previous sub-optimal therapies (mono or bi-therapies) will be allowed. 6) It has been confirmed that in the 6 months prior to inclusion in the study the viral loads have been below 50 copies/mL. 7) On antiretroviral treatment and no treatment-limiting adverse effects with ATV/RTV + 2 nucleoside reverse transcriptase inhibitors (or 1 Nuc + TDF) for at least 8 weeks before the study entry. 8) Men and women, ages 18 or older 9) Both females of child-bearing potential and males must utilize effective barrier contraception. Other contraception in addition to barrier methods is permitted; refer to REYATAZ SmPC (See protocol appendix 2). 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: 1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study. 2) WOCBP using a prohibited contraceptive method. Caution is warranted with coadministration of oral contraceptives (ethinyl estradiol and norethindrone). See protocol Appendix 2. 3) Women who are pregnant or breastfeeding. 4) Women with a positive pregnancy test on enrollment or prior to study drug administration. 5) Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment. 6) Active disease condition which includes: - Moderate to severe hepatic impairment - Active renal disease - History of clinically significant heart conduction disease. 7) Active alcohol or substance use sufficient, in the investigator’s opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis. 8) Patients with chronic hepatitis B receiving 3TC, TDF or FTC. 9) CD4 cell count below 100 cells/mm3. 10) Serum glucose > 500 mg/dL, 11) Sodium serum levels below 115 meq/L and less or above 165 meq/L and Potassium serum levels below 2 meq/L or above 7 meq/L, 12) Liver enzymes (AST, ALT) > 10 times the upper limit of normal, 13) Hemoglobin < 6.5 g/dL, WBC<800/mm3, absolute neutrophil count < 500/mm3, platelets < 20,000/mm3 or diffuse petechiae. 14) Hypersensitivity to any component of the formulation of study drug. 15) The patient will require any of the drugs contraindicated with ATV/RTV. Refer to Protocol Section 6.4.1. 16) Any other clinical conditions or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for study or unable to comply with the dosing requirements. 17) Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the proportion of subjects with virologic rebound (HIV RNA = 400 c/mL) or treatment discontinuation at Week 48 for subjects who received ATV/RTV monotherapy.;Secondary Objective: To evaluate in subjects on ATV/RTV monotherapy: • The proportion of subjects with virologic rebound (HIV RNA = 400 c/mL) at Week 48. • The time to treatment failure defined as the earlier of virologic rebound or treatment discontinuation. • The time to virologic rebound. • The changes in CD4 cell counts from baseline through Week 48. • Safety of maintenance treatment with ATV/RTV monotherapy. • The incidence of resistance to ATV/RTV used as single enhanced protease inhibitor therapy.;Primary end point(s): The proportion of subjects with virologic rebound (HIV RNA = 400 c/mL) or treatment discontinuation at Week 48. | — |
Countries
Spain
Outcome results
None listed