None listed
Conditions
Interventions
THE STUDY WILL CONSIST OF A SCREENING PERIOD OF MAXIMUM 6 WEEKS, A BASELINE VISIT AND A 48-WEEK TREATMENT PERIOD. AFTER THE END OF THE TREATMENT PERIOD, SUBJECTS WITH ONGOING AES WILL BE FOLLOWED FOR
500 HIV-1 RNA COPIES/ML) OR (2) SUBJECTS SWITCHING DUE TO
SIMPLIFICATION OF THEIR CURRENT REGIMEN OR DUE TO AES AND/OR TOLERABILITY REASONS (WITH A SCREENING VIRAL LOAD VALUE < 50 HIV-1 RNA COPIES/
Sponsors
JANSSEN R&D IRELAND,
Eligibility
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. MALE OR FEMALE SUBJECT, AGED 18 YEARS OR ABOVE. 2. SUBJECTS WITH DOCUMENTED HIV -1 INFECTION. 3. TREATMENT WITH CURRENT STABLE HAART FOR AT LEAST 8 WEEKS PRIOR TO SCREENING. NOTE: HAART IS DEFINED AS POTENT ANTI-HIV TREATMENT USUALLY INCLUDING A COMBINATION OF 3 OR MORE DRUGS WITH ACTIVITY AGAINST HIV WHOSE PURPOSE IS TO REDUCE VIRAL LOAD TO < 50 HIV-1 RNA COPIES/ML. 4. TWO GROUPS OF SUBJECTS SWITCHING THEIR CURRENT HAART REGIMEN WILL BE ELIGIBLE: - SUBJECTS EXPERIENCING VIROLOGIC FAILURE, WITH A SCREENING VIRAL LOAD VALUE ≥ 500 HIV-1 RNA COPIES/ML; - SUBJECTS SWITCHING DUE TO SIMPLIFICATION OFTHEIR REGIMEN OR DUE TO AES AND/OR TOLERABILITY REASONS. THESE SUBJECTS SHOULD HAVE A SCREENING VIRAL LOAD VALUE < 50 HIV-1 RNA COPIES/ML. 5. DEMONSTRATED SENSITIVITY TO ETR AND TO AT LEAST 1 AR V IN THE BACKGROUND REGIMEN, BASED ON THE RESISTANCE TEST (USING THE PHENOSENSE G´FTM) AT SCREENING OR RESISTANCE HISTORY FOR THOSE GROUP OF SUBJECTS ENTERING THE STUDY WITH A PLASMA VIRAL LOAD < 50 HIV-1 RNA COPIES/ML. NOTE: IF RAL OR ATV/RTV IS PART OF THE BACKGROUND REGIMEN, SENSITIVITY TO AT LEAST 2 ARVS IN THE BACKGROUND REGIMEN IS REQUIRED.
Exclusion criteria
Exclusion criteria: • 1. PRESENCE OF ANY CURRENTLY ACTIVE AIDS DEFINING ILLNESS (CATEGORY C CONDITIONS ACCORDING TO THE CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) CLASSIFICATION SYSTEM FOR HIV INFECTION 1993; SEE ATTACHMENT 4) WITH THE FOLLOWING EXCEPTIONS: - STABLE CUTANEOUS KAPOSI´S SARCOMA (IE. NO INTERNAL ORGAN INVOLVEMENT OTHER THAN ORAL LESIONS) THAT IS UNLIKELY TO REQUIRE ANY FORM OF SYSTEMIC THERAPY DURING THE STUDY TIME PERIOD. - WASTING SYNDROME. NOTE: PRIMARY AND SECONDARY PROPHYLAXIS FOR AN AIDS DEFINING ILLNESS IS ALLOWED IN CASE THE MEDICATION USED IS NOT PART OFTHE DISALLOWED MEDICATION AS SPECIFIED IN SECTION 8. 2. CURRENT OR PAST ALCOHOL AND/OR DRUG USE WHICH, IN THE INVESTIGATOR´S OPINION, COULD COMPROMISE THE SUBJECT´S SAFETY OR ADHERENCE TO THE STUDY PROTOCOL PROCEDURES. 3. USE OF ANY NON-ARV INVESTIGATIONAL AGENTS WITHIN 90 DAYS PRIOR TO SCREENING. 4. USE OF DISALLOWED CONCOMITANT THERAPIES. (REFER TO SECTION 8.)
Countries
Argentina, France, Guatemala, India, Mexico, Peru, Poland, Puerto Rico, Romania, Russian Federation, South Africa, Ukraine, United States
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed