Trial Outcomes & Findings for Safety and Acceptability Study of Non-occupational Prophylaxis (PEP) Following Potential Exposure to HIV (NCT NCT01602822)
NCT ID: NCT01602822
Last Updated: 2025-07-10
Results Overview
Number of subjects who experienced moderate-to-severe symptoms on the symptom-directed physical exam at or before visit 3.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
11 participants
Primary outcome timeframe
Visit 3- Day 30
Results posted on
2025-07-10
Participant Flow
Participant milestones
| Measure |
Atazanavir, Ritonavir, Truvada
Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir
Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir: TDF 300mg and FTC 200mg fixed-dose combination tablet (TDF/FTC) once daily, and atazanavir, one 300mg tablet and one 100 mg ritonavir given once daily
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Atazanavir, Ritonavir, Truvada
Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir
Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir: TDF 300mg and FTC 200mg fixed-dose combination tablet (TDF/FTC) once daily, and atazanavir, one 300mg tablet and one 100 mg ritonavir given once daily
|
|---|---|
|
Overall Study
Adverse Event
|
11
|
Baseline Characteristics
Safety and Acceptability Study of Non-occupational Prophylaxis (PEP) Following Potential Exposure to HIV
Baseline characteristics by cohort
| Measure |
Atazanavir, Ritonavir, Truvada
n=11 Participants
Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir
Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir: TDF 300mg and FTC 200mg fixed-dose combination tablet (TDF/FTC) once daily, and atazanavir, one 300mg tablet and one 100 mg ritonavir given once daily
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
37 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 3- Day 30Number of subjects who experienced moderate-to-severe symptoms on the symptom-directed physical exam at or before visit 3.
Outcome measures
| Measure |
Atazanavir, Ritonavir, Truvada
n=11 Participants
Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir
Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir: TDF 300mg and FTC 200mg fixed-dose combination tablet (TDF/FTC) once daily, and atazanavir, one 300mg tablet and one 100 mg ritonavir given once daily
|
|---|---|
|
Safety of Regimen - Symptoms
None or Mild
|
4 Participants
|
|
Safety of Regimen - Symptoms
Moderate to Severe
|
7 Participants
|
PRIMARY outcome
Timeframe: visit 3 - day 30Number of subjects who experience adverse or serious adverse events that are considered related to the use of the drug regimen at or before visit 3.
Outcome measures
| Measure |
Atazanavir, Ritonavir, Truvada
n=11 Participants
Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir
Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir: TDF 300mg and FTC 200mg fixed-dose combination tablet (TDF/FTC) once daily, and atazanavir, one 300mg tablet and one 100 mg ritonavir given once daily
|
|---|---|
|
Safety of Regimen - Adverse Events/Serious Adverse Events Considered Related
No related events
|
4 participants
|
|
Safety of Regimen - Adverse Events/Serious Adverse Events Considered Related
1 or more related adverse/serious advers events
|
7 participants
|
PRIMARY outcome
Timeframe: visit 3 - day 30Number of subjects who have an unsafe biological test result as part of the laboratory screen for safety levels (e.g., CBC, Creatinine, etc.) at or before visit 3.
Outcome measures
| Measure |
Atazanavir, Ritonavir, Truvada
n=11 Participants
Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir
Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir: TDF 300mg and FTC 200mg fixed-dose combination tablet (TDF/FTC) once daily, and atazanavir, one 300mg tablet and one 100 mg ritonavir given once daily
|
|---|---|
|
Safety of Regimen - Unsafe Biological Test
no unsafe lab tests
|
4 Participants
|
|
Safety of Regimen - Unsafe Biological Test
1 or more unsafe lab tests
|
7 Participants
|
SECONDARY outcome
Timeframe: Visit 2- Day 14Assess awareness as measured by how many participants had initially heard of NPEP prior to the incident exposure
Outcome measures
| Measure |
Atazanavir, Ritonavir, Truvada
n=11 Participants
Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir
Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir: TDF 300mg and FTC 200mg fixed-dose combination tablet (TDF/FTC) once daily, and atazanavir, one 300mg tablet and one 100 mg ritonavir given once daily
|
|---|---|
|
Awareness of NPEP
number of participants who had heard of nPEP prior to exposure
|
10 Participants
|
|
Awareness of NPEP
Number of participants who had not heard of nPEP prior to exposure
|
1 Participants
|
SECONDARY outcome
Timeframe: Visit 3- Day 30Adherence to the regimen will be assessed by whether the regimen was completed as prescribed or not. χ2 tests will be used to assess differences in the proportion of both completion and adherence between participants in the current study and participants in previous studies of NPEP at Fenway Health (historical controls).
Outcome measures
| Measure |
Atazanavir, Ritonavir, Truvada
n=11 Participants
Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir
Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir: TDF 300mg and FTC 200mg fixed-dose combination tablet (TDF/FTC) once daily, and atazanavir, one 300mg tablet and one 100 mg ritonavir given once daily
|
|---|---|
|
Adherence Rate - Overall
Non-Adherent (30 day)
|
7 Participants
|
|
Adherence Rate - Overall
Adherent (30 day)
|
4 Participants
|
SECONDARY outcome
Timeframe: Visit 2- Day 14Number of participants who had used nPEP prior to participation in the study.
Outcome measures
| Measure |
Atazanavir, Ritonavir, Truvada
n=11 Participants
Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir
Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir: TDF 300mg and FTC 200mg fixed-dose combination tablet (TDF/FTC) once daily, and atazanavir, one 300mg tablet and one 100 mg ritonavir given once daily
|
|---|---|
|
Prior nPEP Use
Number of participants who had used nPEP in their lifetime prior to participating in this study
|
2 Participants
|
|
Prior nPEP Use
Number of participants who had not used nPEP in their lifetime prior to participating in this study.
|
9 Participants
|
SECONDARY outcome
Timeframe: Visit 1- Day 28Number of participants who completed prescribed regimen
Outcome measures
| Measure |
Atazanavir, Ritonavir, Truvada
n=11 Participants
Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir
Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir: TDF 300mg and FTC 200mg fixed-dose combination tablet (TDF/FTC) once daily, and atazanavir, one 300mg tablet and one 100 mg ritonavir given once daily
|
|---|---|
|
Adherence - Degree of Adherence
|
0 Participants
|
Adverse Events
Atazanavir, Ritonavir, Truvada
Serious events: 7 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atazanavir, Ritonavir, Truvada
n=11 participants at risk
Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir
Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir: TDF 300mg and FTC 200mg fixed-dose combination tablet (TDF/FTC) once daily, and atazanavir, one 300mg tablet and one 100 mg ritonavir given once daily
|
|---|---|
|
Hepatobiliary disorders
Grade 3 elevation in liver function tests
|
63.6%
7/11 • Number of events 11
|
Other adverse events
| Measure |
Atazanavir, Ritonavir, Truvada
n=11 participants at risk
Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir
Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir: TDF 300mg and FTC 200mg fixed-dose combination tablet (TDF/FTC) once daily, and atazanavir, one 300mg tablet and one 100 mg ritonavir given once daily
|
|---|---|
|
Gastrointestinal disorders
jaundice
|
27.3%
3/11 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place