Trial Outcomes & Findings for Evaluation of 3TC or FTC Mono-therapy Compared to Continuing HAART as a Bridging Strategy (NCT NCT01338025)

Last Updated: 2015-11-13

Results Overview

Immunologic deterioration was declared for a participant if any one of the following conditions is observed within the first 28 weeks: * greater than or equal to 30% decline in absolute CD4+ T cell count from entry, or * development of CDC class C events. Results report number of participants with immunologic deterioration at week 28 calculated.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

33 participants

Primary outcome timeframe

From entry to week 28

Results posted on

2015-11-13

Participant Flow

Participants were recruited from 17 sites in the United States, Argentina, Brazil and Thailand. Enrollment occurred from May 10, 2011 to January 16, 2013.

Eligible participants were HIV-infected, ≥8 to \<25 years of age with documentation of the M184V HIV resistance mutation, were failing their current antiretroviral regimen and were persistently non-adherent. Participants were randomized equally to the two study arms.

Participant milestones

Participant milestones
Measure	Arm A, Non-suppressive HAART Regimen In Step 1, subjects were randomized to continue their non-suppressive HAART regimen. In Step 2, subjects either began a new HAART regimen, continue randomized treatment, or discontinued therapy while remaining on follow-up, as decided by their provider. HAART regimen: The study participant continued their non-suppressive HAART regimen as prescribed by their primary provider.	Arm B, 3TC or FTC Monotherapy In step 1, subjects were randomized to receive 3TC or FTC (the choice of 3TC or FTC was left to the provider.) In Step 2, subjects either began a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider. 3TC or FTC monotherapy: The study participant was assigned to either 3TC or FTC monotherapy (the choice of 3TC or FTC was left to the provider.)
Overall Study STARTED	16	17
Overall Study COMPLETED	5	6
Overall Study NOT COMPLETED	11	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A, Non-suppressive HAART Regimen In Step 1, subjects were randomized to continue their non-suppressive HAART regimen. In Step 2, subjects either began a new HAART regimen, continue randomized treatment, or discontinued therapy while remaining on follow-up, as decided by their provider. HAART regimen: The study participant continued their non-suppressive HAART regimen as prescribed by their primary provider.	Arm B, 3TC or FTC Monotherapy In step 1, subjects were randomized to receive 3TC or FTC (the choice of 3TC or FTC was left to the provider.) In Step 2, subjects either began a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider. 3TC or FTC monotherapy: The study participant was assigned to either 3TC or FTC monotherapy (the choice of 3TC or FTC was left to the provider.)
Overall Study Unexpected closure of study	10	9
Overall Study Withdrawal by Subject	0	2
Overall Study Found ineligible after starting	1	0

Baseline Characteristics

Evaluation of 3TC or FTC Mono-therapy Compared to Continuing HAART as a Bridging Strategy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A, Non-suppressive HAART Regimen n=15 Participants In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen as prescribed by their primary provider. In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.	Arm B, 3TC or FTC Monotherapy n=17 Participants In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider). In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	9 participants n=7 Participants	18 participants n=5 Participants
Region of Enrollment Argentina	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment Brazil	1 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Thailand	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Screening CD4 count	509 cells/mm3 STANDARD_DEVIATION 176 • n=5 Participants	511 cells/mm3 STANDARD_DEVIATION 277 • n=7 Participants	510 cells/mm3 STANDARD_DEVIATION 232 • n=5 Participants
HIV-1 RNA viral load	4.0 log10 copies/mL STANDARD_DEVIATION 1.0 • n=5 Participants	3.8 log10 copies/mL STANDARD_DEVIATION 0.7 • n=7 Participants	3.9 log10 copies/mL STANDARD_DEVIATION 0.9 • n=5 Participants

PRIMARY outcome

Timeframe: From entry to week 28

Population: All eligible participants who entered the study were included in analyses. One participant on Arm A did not meet entry eligibility criteria; was taken off study after the entry visit, and is therefore excluded from all analyses.

Outcome measures

Outcome measures
Measure	Arm A, Non-suppressive HAART Regimen n=15 Participants In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen. In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider. HAART regimen: The study participant will continue their non-suppressive HAART regimen as prescribed by their primary provider.	Arm B, 3TC or FTC Monotherapy n=17 Participants In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider). In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider. 3TC or FTC monotherapy: The study participant will be assigned to either 3TC/FTC monotherapy (the choice of 3TC or FTC will be left to the provider.
Number of Participants With Immunologic Deterioration	0 participants	5 participants

SECONDARY outcome

Timeframe: Entry to week 28

Population: All eligible participants with CD4+ cell count results available at entry and at week 28.

Change in CD4+ T cell count from entry to Week 28 (CD4+ at entry - CD4+ at Week 28).

Outcome measures

Outcome measures
Measure	Arm A, Non-suppressive HAART Regimen n=6 Participants In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen. In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider. HAART regimen: The study participant will continue their non-suppressive HAART regimen as prescribed by their primary provider.	Arm B, 3TC or FTC Monotherapy n=8 Participants In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider). In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider. 3TC or FTC monotherapy: The study participant will be assigned to either 3TC/FTC monotherapy (the choice of 3TC or FTC will be left to the provider.
Change in CD4+ T Cell Count	27.5 CD4+ T cell count/mL Interval -44.0 to 45.0	76 CD4+ T cell count/mL Interval 1.5 to 222.0

SECONDARY outcome

Timeframe: 28 Weeks

Population: All eligible participants with HIV-1 RNA results available at entry and at week 28.

Change in HIV-1 RNA levels from Entry to Week 28

Outcome measures

Outcome measures
Measure	Arm A, Non-suppressive HAART Regimen n=8 Participants In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen. In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider. HAART regimen: The study participant will continue their non-suppressive HAART regimen as prescribed by their primary provider.	Arm B, 3TC or FTC Monotherapy n=6 Participants In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider). In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider. 3TC or FTC monotherapy: The study participant will be assigned to either 3TC/FTC monotherapy (the choice of 3TC or FTC will be left to the provider.
Change in HIV-1 RNA Levels	3087 copies/mL	-2241 copies/mL Interval to -680.0

SECONDARY outcome

Timeframe: 28 Weeks

Population: All eligible participants with adherence data available at week 28.

Number of participants reporting a missed medication dose in the past 3 days.

Outcome measures

Outcome measures
Measure	Arm A, Non-suppressive HAART Regimen n=6 Participants In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen. In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider. HAART regimen: The study participant will continue their non-suppressive HAART regimen as prescribed by their primary provider.	Arm B, 3TC or FTC Monotherapy n=7 Participants In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider). In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider. 3TC or FTC monotherapy: The study participant will be assigned to either 3TC/FTC monotherapy (the choice of 3TC or FTC will be left to the provider.
Number of Participants Non-adherent as Measured by 3-day Recall	3 participants	1 participants

Adverse Events

Arm A, Non-suppressive HAART Regimen

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Arm B, 3TC or FTC Monotherapy

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Melissa Allen, Director, IMPAACT Operations Center

Family Health International (FHI 360)

Phone: (919) 405-1429

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Arm A, Non-suppressive HAART Regimen n=16 participants at risk In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen as prescribed by their primary provider. In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.	Arm B, 3TC or FTC Monotherapy n=17 participants at risk In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider). In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	5.9% 1/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Cardiac disorders Bradycardia	0.00% 0/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	5.9% 1/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Ear and labyrinth disorders Cerumen impaction	6.2% 1/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	0.00% 0/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Ear and labyrinth disorders Ear pain	6.2% 1/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	5.9% 1/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Ear and labyrinth disorders Otorrhoea	0.00% 0/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	5.9% 1/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Eye disorders Conjunctivitis	0.00% 0/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	11.8% 2/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Gastrointestinal disorders Diarrhoea	0.00% 0/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	5.9% 1/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Gastrointestinal disorders Flatulence	6.2% 1/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	0.00% 0/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Gastrointestinal disorders Nausea	12.5% 2/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	5.9% 1/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Gastrointestinal disorders Vomiting	12.5% 2/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	0.00% 0/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
General disorders Axillary pain	6.2% 1/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	0.00% 0/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
General disorders Chest discomfort	0.00% 0/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	5.9% 1/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
General disorders Chest pain	6.2% 1/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	0.00% 0/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
General disorders Fatigue	0.00% 0/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	5.9% 1/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
General disorders Malaise	6.2% 1/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	0.00% 0/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
General disorders Pyrexia	6.2% 1/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	5.9% 1/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Infections and infestations Acarodermatitis	0.00% 0/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	5.9% 1/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Infections and infestations Body tinea	0.00% 0/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	5.9% 1/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Infections and infestations Cutaneous larva migrans	6.2% 1/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	0.00% 0/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Infections and infestations Ear infection bacterial	6.2% 1/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	0.00% 0/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Infections and infestations Furuncle	6.2% 1/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	0.00% 0/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Infections and infestations Hordeolum	0.00% 0/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	5.9% 1/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Infections and infestations Impetigo	0.00% 0/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	5.9% 1/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Infections and infestations Infection protozoal	0.00% 0/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	5.9% 1/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Infections and infestations Lice infestation	6.2% 1/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	0.00% 0/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Infections and infestations Nasopharyngitis	0.00% 0/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	5.9% 1/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Infections and infestations Otitis externa	0.00% 0/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	5.9% 1/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Infections and infestations Otitis media	6.2% 1/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	0.00% 0/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Infections and infestations Pharyngitis	12.5% 2/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	0.00% 0/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Infections and infestations Pneumonia	6.2% 1/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	0.00% 0/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Infections and infestations Purulent discharge	0.00% 0/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	5.9% 1/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Infections and infestations Rash pustular	0.00% 0/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	5.9% 1/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Infections and infestations Skin bacterial infection	6.2% 1/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	0.00% 0/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Infections and infestations Subcutaneous abscess	6.2% 1/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	0.00% 0/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Infections and infestations Tonsillitis	0.00% 0/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	11.8% 2/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Infections and infestations Vaginitis bacterial	0.00% 0/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	5.9% 1/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Injury, poisoning and procedural complications Ligament sprain	6.2% 1/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	0.00% 0/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Injury, poisoning and procedural complications Post procedural complication	6.2% 1/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	0.00% 0/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Injury, poisoning and procedural complications Procedural pain	6.2% 1/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	0.00% 0/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.
Investigations Alanine aminotransferase abnormal	6.2% 1/16 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.	5.9% 1/17 • From study enrollment until study completion or discontinuation. Expedited adverse event (AE) reporting followed requirements, definitions and methods for expedited reporting of Adverse Events (AEs) as outlined in Version 2.0 of the DAIDS EAE Manual, available on the RSC website at http://rsc.tech-res.com/safetyandpharmacovigilance/.