Enrollment Closed for SWORD Studies
Congratulations on the completion of recruitment into the 201636 (SWORD-1), 201637 (SWORD-2), and the DEXA 202094 sub study!

Thank you for your dedication and all your hard work on the SWORD and DEXA studies over these past few months. We acknowledge the time and effort you have put into identifying and screening patients.

As enrollment has officially ended, our focus is now retaining subjects, ensuring that study visits are performed on time and collecting high-quality data from these studies. Below are a few reminders to encourage compliance to study visits and procedures:

Financial Limitations
Available Initiative: Patient Reimbursement Program (managed by MMG, United States, Canada, and Netherlands Only)

  • Please remind subjects that there is a $1 USD fee to withdraw funds from a bank teller. Subjects can check the balance of their cards via the Internet (www.payoneer.com) or by calling the toll-free number listed in the FAQ document.

Travel Issues
Available Initiative: Transportation Program (managed by MMG, United States only); relocation assistance (CRAs will work with Central team to assist with subject transfers); transportation support via study site or through local approved channels (not managed by MMG).

Communication with Subjects
It is recommended that all subjects provide details for an alternative contact person. In case the subject is unreachable, having an alternative contact name and phone number may help you locate the subject.

Frequent phone communication with each subject is critical to ensure proper follow up and visits are completed on time. This is especially important, as study fatigue may begin to set in with subjects who have been enrolled for a long period of time and who are feeling well. Regular follow up maintains rapport and helps to remind subjects about study visits and the importance of taking study medication at the same time daily and with a meal. This will help to reduce the chance for virologic failure due to poor medication adherence. We recommend sites:

  • Contact subjects at least one week prior to reconfirm their appointment and remind them of any special visit procedures. Also contact subjects one day prior to each visit to again reconfirm.
  • Remind subjects to bring ALL their study medication bottles to each visit.
  • Proactively discuss any issues regarding study procedures and compliance with subjects to help find a solution to any issues identified.
  • Explain the study requirements at each visit to ensure subjects are aware of study requirements and understand the importance of long-term compliance. These include:
    • Confirming that female subjects are either using birth control or abstaining from sex to prevent pregnancy and subsequent withdrawal from the study
    • Ensuring subjects report any medical changes since starting treatment, even if they believe the symptoms to be mild or unrelated to treatment.
    • Counseling subjects on taking investigational product at the same time everyday with a meal and discussing the consequences of missing a dose of study medications.

Please note that initiatives and tools may vary based on EC/IRB permissions.

PK Reminders
  • No more PK samples should be drawn at weeks 2 or 8. These PK samples were only required for approximately the first 20 subjects switching for EFV- or NVP-based regimens to DTG + RPV, and this “PK subset” is closed. Any samples collected at weeks 2 and 8 will be considered a protocol deviation and subsequently discarded.
  • PK at Week 4 should still be collected for subjects who switch to DTG + RPV.
  • No PK should be collected for subjects in the CAR arm.
  • Following Week 4, the next PK visit scheduled for subjects randomized to receive DTG + RPV is at Week 24.

Virologic Withdrawal Reminders
  • Study virologists will monitor HIV RNA levels of subjects and flag elevations in HIV RNA (> 50 copies/mL) to the CILs. CILs will inform the investigator and copy the LOC monitors.
  • As referenced in 5.4.1, Figure 2 of the protocol, CILs will send an email for:
    • Current plasma HIV-1 RNA ≥ 50 c/mL but < 200 c/mL: Subject has met “Additional plasma HIV-1 RNA Testing Criterion or possible withdrawal”
    • Current plasma HIV-1 RNA ≥ 200 c/mL (If previous plasma HIV-1 RNA was < 50 c/mL): Subject has met “Suspected Virologic Withdrawal Criterion”
    • Current plasma HIV-1 RNA ≥ 200 c/mL (If previous plasma HIV-1 RNA was 50 c/mL): Subject has met “Confirmed Virologic Withdrawal Criterion”

Only plasma HIV-1 RNA values determined by the central laboratory will be used to assess virologic failure. Upon notification that a subject’s HIV-1 RNA plasma level qualifies him/her as a suspected virologic failure/meeting a suspected endpoint, the investigator should query the subject regarding intercurrent illness, recent immunization, or interruption of therapy. The following guidelines will be followed for scheduling confirmatory HIV-1 RNA testing in an effort to avoid false positive results:

  • Confirmatory testing should be scheduled approximately 2 to 4 weeks following resolution of any intercurrent illness, during which time the subject should receive the full dose of all IP.
  • Confirmatory testing should be scheduled at least 4 weeks following any immunization, during which time the subject should receive the full dose of IP.
  • If therapy is interrupted due to toxicity management, non-compliance, or other reasons, confirmatory testing should be scheduled 2 to 4 weeks following resumption of the full dose of IP.
  • The subject should have received the full doses of IP for at least 2 weeks at the time confirmatory plasma HIV-1 RNA is done.
  • If a subject has been on holiday or has had other personal issues that raise any questions about whether he or she has been fully adherent to therapy, then you should contact the medical monitor to discuss whether or not you should wait to obtain the HIV-1 RNA sample until you are certain that the subject has been on the full dose of IP for at least 2 weeks. Sites should contact the medical monitor to discuss individual subjects, whenever necessary.


Summary of site assessments scheduled or occurred so far by GSK Clinical Compliance

SWORD 1

Two sites selected in Spain and Taiwan, Q4 2015

SWORD 2

Two sites selected in Spain and Taiwan, Q4 2015

One site in Australia assessed in August 2015

DEXA 202094

Two sites to be assessed; one in Argentina (Q4 2015) and the second to be confirmed.

Regulatory Agency Inspections:

1 site in Canada inspected in September 2015

Guidance on filing ERT eC-SSRS and RAMOS NG reports and Health Outcomes Questionnaires
What to file and where?
ERT eC-SSRS survey reports Completed by subject via phone or ERT website Print each eC-SSRS survey for every subject and file in site study file
Paper questionnaires:
  • EQ-5D-5L questionnaire
  • Symptom Distress Module (Symptom Impact Questionnaire)
  • HIV TSQ
  • Adherance by Visual Analogue Scale
 Completed by subject on paper form File in site study file
RAMOS NG visit reports Generated in RAMOS NG for randomization and dispensing transactions Print and file only the randomization visit report for each subject in site study file


DEXA 202094 Study ICF Revision
Version 2 of the DEXA 202094 study ICF was distributed on Friday, 25 September. Please submit the ICF v2 to your EC/IRB and regulatory authority, if appropriate. A few things of note:
  • DEXA 202094 study ICF v2 has been submitted to the central IRB in the United States
  • The DEXA 202094 study v2 ICF has been posted to eDX
  • Please remind your sites that all subjects must be re-consented with v2 of the DEXA ICF
  • The two main changes in v2 of the DEXA ICF are:
    • The collection of month of birth (needed for the calculation of bone mineral density Z-scores)
    • A statement informing subjects they may need to have a DEXA scan repeated if there are any technical issues with the original scans upon QC review by Parexel