Phase 2
N=267
Interventions for HIV Negative Men and Women Who Have High-risk Suspected Exposure to HIV
HIV Prevention · HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00949234 ↗Enrolled (actual)
267
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Retention, Measured as the Number of HIV Exposure Events That Were Retained in Care at the 24 Week Follow-up Visit — 125; 157 HIV Exposure Events — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- tenofovir + emtricitabine, lopinavir/ritonavir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Retention, Measured as the Number of HIV Exposure Events That Were Retained in Care at the 24 Week Follow-up Visit |
125; 157 | <0.05 sig |
Summary
The purpose of this program is to evaluate an effort to provide a comprehensive package of HIV prevention services of which post-exposure prophylaxis (medicines that may help prevent HIV infection after an exposure) can be a part. It will also include risk reduction information and testing for other sexually transmitted infections.
Eligibility Criteria
Inclusion Criteria
- Patients must be at least 18 years of age
- Able to understand and provide consent
- High-Risk Exposure Characteristic
- (one or more of the below, unprotected or with failed condom use)
- Receptive Anal Intercourse
- Insertive Anal Intercourse
- Receptive Vaginal Intercourse
- Insertive Vaginal Intercourse
- Receptive Oral Intercourse with Intraoral Ejaculation with known HIV+ source (supersedes all "high-risk source" criteria below)
- Sharing injection drug works which have been intravascular
- High-Risk Source (one or more of the below)
- Known HIV positive
- MSM
- MSM/W
- IDU
- CSW
- Sexual perpetrator
- From an endemic country (prevalence >1%)
- Partner of one of the above
- Exposure within 72 hours of presentation
- Not known to be HIV positive
- No countermanding concomitant medications or allergies
- HIV-negative on presentation and without symptoms of PHI (do not withhold first dose pending these laboratory assessments).
Exclusion Criteria
- Patients 72 hours of presentation
- Known to be HIV positive
- Currently in-progress of a course of PEP initiated via non-P-QUAD mechanisms
- Any condition, which in the opinion of the intake provider, will seriously compromise the patient's ability to comply with the protocol, including
- adherence to PEP medication dosing
- Demonstrated HIV-positive on rapid testing
- Unwillingness to commit to barrier-method (male and/or female condom) use until HIV-negative-status is confirmed 6 months after exposure
- Unwillingness of breast-feeding women to transition to formula feeding
Data sourced from ClinicalTrials.gov (NCT00949234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.