HIV Non Occupational Post-Exposure Prophylaxis (PEP)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
This study will evaluate a three drug regimen in the form of two pills which will be taken for 28 days for the prevention of HIV infection. Two drugs are combined in an FDA-approved pill called TRUVADA, containing the HIV medications, tenofovir disoproxil fumarate 300mg and emtricitabine 200mg, taken as one pill once a day. The third drug is a new formulation, raltegravir 400mg pill taken twice a day.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Group 1 TRUVADA + raltegravir |
Drug: TRUVADA + raltegravir
TRUVADA (tenofovir disoproxil fumarate (DF) 300mg + emtricitabine 200mg) + RALTEGRAVIR 400mg
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Medication Regimen Completion Rates [28 days]
Pill counts performed at 14 and 28 days
- Number of HIV-1 Infected Participants [90 days]
Of participants that were evaluable at 3 months post initiation of treatment, how many became HIV-1 infected
Eligibility Criteria
Criteria
Inclusion Criteria:
-
HIV uninfected on the basis of a negative HIV Rapid Test, EIA or Western blot, and a negative HIV-1 RNA assay
-
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.
-
Able to understand the study procedures and willing to sign informed consent
Exclusion Criteria:
-
Any active psychiatric illness or active drug or alcohol abuse that, in the opinion of the investigator, could prevent compliance with study procedures.
-
Pregnancy.
-
Chronic hepatitis B infection, diagnosed by either positive serum HBsAg or positive serum HBV DNA; or prior lamivudine therapy for hepatitis B.
-
Creatinine clearance less than 50 mL/min as calculated by Cockcroft-Gault formula.
-
Unwillingness to participate in study procedures, including Mental Health referral and intervention.
-
Known intolerance or allergy to tenofovir DF, emtricitabine or raltegravir.
-
Use of prohibited concomitant medication: dilantin, phenobarbital and rifampin which cannot be used with raltegravir.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fenway Community Health | Boston | Massachusetts | United States | 02115 |
Sponsors and Collaborators
- Fenway Community Health
- Merck Sharp & Dohme LLC
Investigators
- Principal Investigator: Kenneth H Mayer, MD, Fenway Community Health
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- MK PEP 2007
Study Results
Participant Flow
| Recruitment Details | Participants were recruited from Fenway Health. Patients at least 18 years of age, who contacted Fenway Health and presented within 72 hours after a potential sexual exposure to HIV-1 were asked to participate in this study. |
|---|---|
| Pre-assignment Detail | If study coordinator is notified more than 72 hours after exposure occurred, person will not be eligible for study participation; however they will be referred to an on call medical provider for Non Occupational Post-Exposure Prophylaxis evaluation. |
| Arm/Group Title | Group 1 |
|---|---|
| Arm/Group Description | Men or women, 18 years of age or older, who present within 72 hours of a potential non-occupational exposure to HIV-1. |
| Period Title: Overall Study | |
| STARTED | 100 |
| COMPLETED | 84 |
| NOT COMPLETED | 16 |
Baseline Characteristics
| Arm/Group Title | Group 1 |
|---|---|
| Arm/Group Description | TRUVADA (tenofovir DF 300mg + emtricitabine 200mg) + raltegravir (400mg) |
| Overall Participants | 100 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
100
100%
|
| >=65 years |
0
0%
|
| Age (years) [Mean (Full Range) ] | |
| Mean (Full Range) [years] |
33.3
|
| Sex: Female, Male (Count of Participants) | |
| Female |
2
2%
|
| Male |
98
98%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
2
2%
|
| Native Hawaiian or Other Pacific Islander |
3
3%
|
| Black or African American |
11
11%
|
| White |
71
71%
|
| More than one race |
13
13%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
100
100%
|
Outcome Measures
| Title | Medication Regimen Completion Rates |
|---|---|
| Description | Pill counts performed at 14 and 28 days |
| Time Frame | 28 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Group 1 |
|---|---|
| Arm/Group Description | TDF 300mg + FTC 200mg (TDF/FTC) once daily + raltegravir 400mg twice daily |
| Measure Participants | 100 |
| Completed as perscribed |
57
57%
|
| Stopped or Modified regimen |
28
28%
|
| Lost to follow-up |
15
15%
|
| Title | Number of HIV-1 Infected Participants |
|---|---|
| Description | Of participants that were evaluable at 3 months post initiation of treatment, how many became HIV-1 infected |
| Time Frame | 90 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants evaluable at 3 months (90 days) after treatment initiation |
| Arm/Group Title | Group 1 |
|---|---|
| Arm/Group Description | TRUVADA (tenofovir DF 300mg + emtricitabine 200mg) + raltegravir (400mg) |
| Measure Participants | 85 |
| Number [participants] |
0
0%
|
Adverse Events
| Time Frame | 28 days | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Group 1 | |
| Arm/Group Description | TDF 300mg and FTC 200mg (TDF/FTC) once daily + raltegravir (400mg) twice daily | |
All Cause Mortality |
||
| Group 1 | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Group 1 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/100 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Group 1 | ||
| Affected / at Risk (%) | # Events | |
| Total | 93/100 (93%) | |
| Gastrointestinal disorders | ||
| Diarrhea / Loose Stool / Soft Stool | 21/100 (21%) | |
| Abdominal discomfort, pain, gas, or bloating | 16/100 (16%) | |
| Nausea/vomiting | 27/100 (27%) | |
| Investigations | ||
| Fatigue | 14/100 (14%) | |
| Nervous system disorders | ||
| Headache | 15/100 (15%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Kenneth Mayer |
|---|---|
| Organization | Fenway Health |
| Phone | 617-927-6400 |
| kmayer@fenwayhealth.org |
- MK PEP 2007