INFECTION HIV MedDRA version: 9.1 Level: LLT Classification code 10020159 Term: HIV carrier
Conditions
Interventions
Trade Name: APTIVUS
Pharmaceutical Form: Capsule, soft
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Trade Name: NORVIR
Pharmaceutical Form: Capsule, soft
Sponsors
AZIENDA OSPEDALIERA OSPEDALI RIUNITI DI BERGAMO A.O. DI RILIEVO NAZIONALE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: AGE 18 YEARS; INFORMED CONSENT SIGNED; BEING ON A CURRENTLY FAILING HAART HIV-RNA 50 COPIES/ML HAVING A GENOTYPE PERFORMED SHOWING RESISTANCE TO BOTH NRTIS AT LEAST 3 DRUGS OF THE CLASS AND NNRTIS. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: CHILDBEARING OR BREASTFEEDING. WOMEN OF CHILDBEARING POTENTIAL WILL BE ASKED TO ADOPT EFFECTIVE CONTRACEPTIVE METHODS OR BEHAVIORS ; ANY MAJOR PROTEASE MUTATION. THE ONLY PRIMARY PROTEASE ADMITTED MUTATION WILL BE D30N. PATIENTS SHOWING GENETIC VARIANTS I.E. L63P WILL BE ADMITTED
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: PRIMARY OBJECTIVE OF THE STUDY IS TO VERIFY THE FEASIBILITY OF A SINGLE DRUG HAART IN PRE-TREATED HIV-INFECTED PATIENTS HOSTING A VIRUS WITH MULTIPLE RT MUTATIONS. TWO MAJOR GOALS WILL BE ANALYZED THE POSSIBILITY TO REDUCE HIV-RNA BELOW THE DETECTION LIMIT 50 COPIES/ML THE IMMUNOLOGICAL RESPONSE TO THE NEW THERAPY;Secondary Objective: THE SECONDARY END-POINT OF THE STUDY IS TO VERIFY THE VIROLOGIC SAFETY OF THE STRATEGY;Primary end point(s): THE PRIMARY OBJECTIVE OF THE STUDY WILL BE EVALUATED ON THE BASIS OF 2 END-POINTS. THE FIRST ONE, PURELY VIROLOGIC, WILL BE THE PROPORTION OF SUBJECTS WITH A PLASMA HIV-RNA 50 COPIES/ML AT THE END OF THE FOLLOW-UP PERIOD; THE SECOND WILL BE BASED ON A COMPOSITE OUTCOME COMBINING THE VIROLOGIC RESPONSE AND THE IMMUNOLOGIC RESPONSE. IN THIS CASE RESPONDERS WILL BE DEFINED AS PATIENTS THAT, AT THE END OF THE FOLLOW-UP PERIOD, WILL SHOW AN HIV-RNA 50 COPIES/ML AND A CD4 GAIN OF AT LEAST 50 CELLS/MICROL. THE SECONDARY OBJECTIVE OF THE STUDY WILL BE ANALYZED BY MEANS OF THE GENOTYPIC VARIATIONS OF THE INFECTING VIRUS. A HIGH SENSITIVE GENOTYPIC TEST ALLOWING THE DETERMINATION OF THE MUTATIONAL PATTERN OF HIV WITH A LIMIT OF VIRAL LOAD OF 50 COPIES/ML WILL BE PERFORMED AT EACH VISIT. REVERSE TRANSCRIPTASE, PROTEASE AND THE CLEAVAGE GAG/POL GENE WILL BE SEQUENCED | — |
Countries
Italy
Outcome results
None listed