HIVPhase 4NCT01602822

Safety and Acceptability Study of Non-occupational Prophylaxis (PEP) Following Potential Exposure to HIV

A Phase 4 study testing Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir in people with HIV, run by Kenneth H. Mayer, MD at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: HIV
What is being tested?: Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteUnited States
Study dates: Feb 2012to May 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age of 18 at time of first visit.
HIV uninfected on the basis of a negative HIV Rapid Test
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.

Who cannot join

Women who are actively trying to become pregnant.
Pregnancy and/or Breastfeeding.
Known self report of Chronic Hepatitis B infection or prior antiretroviral therapy for hepatitis B.
Known intolerance or allergy to study drugs.

Trial locations and contacts

1 site in 1 country.

United States1 site

Fenway Health
Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: A Phase IV Open-label Evaluation of Safety, Tolerability and Patient Acceptance of Atazanavir Boosted With Ritonavir Combined With a Fixed-dose Formulation of Tenofovir DF and Emtricitabine for nPEP Following Potential Exposure to HIV-1

Read the 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.

Conditions: HIV
Being tested: Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir
Keywords: HIV Prevention, Non-occupational Post-Exposure Prophylaxis (NPEP), Post-Exposure Prophylaxis (PEP)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tenofovir DF and Emtricitabine; Ritonavir-boosted AtazanavirDrug
Also called Truvada
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

Study groups in NCT01602822
Study group	Role	What they receive
Atazanavir, Ritonavir, Truvada	Other	Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir Receives: Drug: Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety of Regimen - Symptoms
Number of subjects who experienced moderate-to-severe symptoms on the symptom-directed physical exam at or before visit 3.
Measured: Visit 3- Day 30
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.
Measured: visit 3 - day 30
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.
Measured: visit 3 - day 30

Secondary outcomes (4)

Awareness of NPEP
Assess awareness as measured by how many participants had initially heard of NPEP prior to the incident exposure
Measured: Visit 2- Day 14
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).
Measured: Visit 3- Day 30
Prior nPEP Use
Number of participants who had used nPEP prior to participation in the study.
Measured: Visit 2- Day 14
Adherence - Degree of Adherence
Number of participants who completed prescribed regimen
Measured: Visit 1- Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012May 2012

First posted21 May 2012 (estimated)
Study startFeb 2012
Primary completionMay 2012
Study completionMay 2012

Why it stopped: Grade 3 elevation in liver function tests

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIVStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Model description: Open-label phase IV study of a new regimen for antiretroviral post-exposure prophylaxis
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01602822
Sponsor's protocol ID: BMS PEP
Status last verified: Jun 2025
First submitted: 8 Feb 2012
Last updated: 10 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: De-identified participant data describing the adverse events will be available for review upon request

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All HIV trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IV Open-label Evaluation of Safety, Tolerability and Patient Acceptance of Atazanavir Boosted With Ritonavir Combined With a Fixed-dose Formulation of Tenofovir DF and Emtricitabine for nPEP Following Potential Exposure to HIV-1
ClinicalTrials.gov ID: NCT01602822
Acronym / sponsor ID: BMS PEP
Conditions: HIV
Keywords: HIV Prevention, Non-occupational Post-Exposure Prophylaxis (NPEP), Post-Exposure Prophylaxis (PEP)
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Grade 3 elevation in liver function tests
Enrolment: 11 participants (actual)
Lead sponsor: Kenneth H. Mayer, MDUniversity, hospital or other
Collaborators: Bristol-Myers Squibb, Gilead Sciences, Abbott
Study start: Feb 2012
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 21 May 2012 (estimated)
Results: Posted 2 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Open-label phase IV study of a new regimen for antiretroviral post-exposure prophylaxis

Arm	Type	Receives
Atazanavir, Ritonavir, Truvada	Other	Drug: Tenofovir DF and Emtricitabine; Ritonavir-boosted AtazanavirTenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age of 18 at time of first visit.
HIV uninfected on the basis of a negative HIV Rapid Test
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.

Key exclusion criteria (4 listed)

Women who are actively trying to become pregnant.
Pregnancy and/or Breastfeeding.
Known self report of Chronic Hepatitis B infection or prior antiretroviral therapy for hepatitis B.
Known intolerance or allergy to study drugs.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tenofovir DF and Emtricitabine; Ritonavir-boosted AtazanavirAlso: TruvadaTDF 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	Drug	Atazanavir, Ritonavir, Truvada

Primary outcome

Safety of Regimen - Symptoms
Time frame: 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
Time frame: 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
Time frame: 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.

4 secondary outcomes

Awareness of NPEP
Time frame: Visit 2- Day 14
Adherence Rate - Overall
Time frame: Visit 3- Day 30
Prior nPEP Use
Time frame: Visit 2- Day 14
Adherence - Degree of Adherence
Time frame: Visit 1- Day 28

Results and safety

Results posted to the registry on 2 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Atazanavir, Ritonavir, Truvada	11	0

Primary outcome: Safety of Regimen - Symptoms

Time frame: Visit 3- Day 30. Count of participants. Unit: Participants

Measure	Atazanavir, Ritonavir, Truvada n = 11
None or Mild	4
Moderate to Severe	7

Primary outcome: Safety of Regimen - Adverse Events/Serious Adverse Events Considered Related

Time frame: visit 3 - day 30. Number. Unit: participants

Measure	Atazanavir, Ritonavir, Truvada n = 11
No related events	4
1 or more related adverse/serious advers events	7

Primary outcome: Safety of Regimen - Unsafe Biological Test

Time frame: visit 3 - day 30. Count of participants. Unit: Participants

Measure	Atazanavir, Ritonavir, Truvada n = 11
no unsafe lab tests	4
1 or more unsafe lab tests	7

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Atazanavir, Ritonavir, Truvada	7 of 11 (63.6%)	3 of 11 (27.3%)	0 of 11

Limitations and caveats (from the sponsor): Study terminated early as a result of Grade 3 and Grade 4 elevations in liver function tests

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Fenway Health homepageLink provided by the sponsor.
Individual participant dataSharing planned: No. De-identified participant data describing the adverse events will be available for review upon request

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kenneth H Mayer, MD principal investigator

Fenway Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir in people with HIV, run by Kenneth H. Mayer, MD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of Regimen - Symptoms (time frame: Visit 3- Day 30). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01602822.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.