AN OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF ETRAVIRINE (ETR) IN COMBINATION WITH OTHER ANTIRETROVIRALS (ARVS) IN ANTIRETROVIRAL TREATMENT-EXPERIENCED HIV-1 INFECTED SUBJECTS.
- Registration Number
- PER-023-12
- Lead Sponsor
- JANSSEN R&D IRELAND,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Not specified
- Target Recruitment
- 10
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.
• 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.)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method