HIV
Conditions
Keywords
HIV Prevention, Non-occupational Post-Exposure Prophylaxis (NPEP), Post-Exposure Prophylaxis (PEP)
Brief summary
This study will evaluate how safe and tolerable a combination of taking three-drugs will be for the purpose of preventing HIV transmission after a high-risk sexual contact exposure in HIV uninfected adults.
Detailed description
Participants are given a regimen containing tenofovir disoproxil fumarate (TDF) 300mg and emtricitabine (FTC) 200mg fixed-dose combination tablet (TDF/FTC) once daily, and atazanavir, one 300mg tablet and one 100 mg ritonavir given once daily,for 28 days.
Interventions
DRUGTenofovir 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
Sponsors
Bristol-Myers Squibb
Gilead Sciences
Abbott
Kenneth H. Mayer, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Open-label phase IV study of a new regimen for antiretroviral post-exposure prophylaxis
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age of 18 at time of first visit. 2. HIV uninfected on the basis of a negative HIV Rapid Test 3. Possible non-occupational exposure to HIV-1, recent enough to permit receiving the first dose of study medication within 72 hours from the end of the exposure.
Exclusion criteria
1. Women who are actively trying to become pregnant. 2. Pregnancy and/or Breastfeeding. 3. Known self report of Chronic Hepatitis B infection or prior antiretroviral therapy for hepatitis B. 4. Known intolerance or allergy to study drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Regimen - Symptoms | Visit 3- Day 30 | Number of subjects who experienced moderate-to-severe symptoms on the symptom-directed physical exam at or before visit 3. |
| Safety of Regimen - Adverse Events/Serious Adverse Events Considered Related | visit 3 - day 30 | Number 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. |
| Safety of Regimen - Unsafe Biological Test | visit 3 - day 30 | Number 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Awareness of NPEP | Visit 2- Day 14 | Assess awareness as measured by how many participants had initially heard of NPEP prior to the incident exposure |
| Adherence - Degree of Adherence | Visit 1- Day 28 | Number of participants who completed prescribed regimen |
| Adherence Rate - Overall | Visit 3- Day 30 | Adherence 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). |
| Prior nPEP Use | Visit 2- Day 14 | Number of participants who had used nPEP prior to participation in the study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 11 |
Baseline characteristics
| Characteristic | Atazanavir, Ritonavir, Truvada |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 37 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 3 / 11 |
| serious Total, serious adverse events | 7 / 11 |
Outcome results
Primary
Safety of Regimen - Adverse Events/Serious Adverse Events Considered Related
Number 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.
Time frame: visit 3 - day 30
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atazanavir, Ritonavir, Truvada | Safety of Regimen - Adverse Events/Serious Adverse Events Considered Related | No related events | 4 participants |
| Atazanavir, Ritonavir, Truvada | Safety of Regimen - Adverse Events/Serious Adverse Events Considered Related | 1 or more related adverse/serious advers events | 7 participants |
Primary
Safety of Regimen - Symptoms
Number of subjects who experienced moderate-to-severe symptoms on the symptom-directed physical exam at or before visit 3.
Time frame: Visit 3- Day 30
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Atazanavir, Ritonavir, Truvada | Safety of Regimen - Symptoms | None or Mild | 4 Participants |
| Atazanavir, Ritonavir, Truvada | Safety of Regimen - Symptoms | Moderate to Severe | 7 Participants |
Primary
Safety of Regimen - Unsafe Biological Test
Number 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.
Time frame: visit 3 - day 30
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Atazanavir, Ritonavir, Truvada | Safety of Regimen - Unsafe Biological Test | no unsafe lab tests | 4 Participants |
| Atazanavir, Ritonavir, Truvada | Safety of Regimen - Unsafe Biological Test | 1 or more unsafe lab tests | 7 Participants |
Secondary
Adherence - Degree of Adherence
Number of participants who completed prescribed regimen
Time frame: Visit 1- Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Atazanavir, Ritonavir, Truvada | Adherence - Degree of Adherence | 0 Participants |
Secondary
Adherence Rate - Overall
Adherence 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).
Time frame: Visit 3- Day 30
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Atazanavir, Ritonavir, Truvada | Adherence Rate - Overall | Non-Adherent (30 day) | 7 Participants |
| Atazanavir, Ritonavir, Truvada | Adherence Rate - Overall | Adherent (30 day) | 4 Participants |
Secondary
Awareness of NPEP
Assess awareness as measured by how many participants had initially heard of NPEP prior to the incident exposure
Time frame: Visit 2- Day 14
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Atazanavir, Ritonavir, Truvada | Awareness of NPEP | number of participants who had heard of nPEP prior to exposure | 10 Participants |
| Atazanavir, Ritonavir, Truvada | Awareness of NPEP | Number of participants who had not heard of nPEP prior to exposure | 1 Participants |
Secondary
Prior nPEP Use
Number of participants who had used nPEP prior to participation in the study.
Time frame: Visit 2- Day 14
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Atazanavir, Ritonavir, Truvada | Prior nPEP Use | Number of participants who had used nPEP in their lifetime prior to participating in this study | 2 Participants |
| Atazanavir, Ritonavir, Truvada | Prior nPEP Use | Number of participants who had not used nPEP in their lifetime prior to participating in this study. | 9 Participants |