Interventions for HIV Negative Men and Women Who Have High-risk Suspected Exposure to HIV
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00949234 |
|
Recruitment Status
:
Completed
First Posted
: July 30, 2009
Results First Posted
: December 18, 2017
Last Update Posted
: December 18, 2017
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Prevention HIV Infections | Drug: tenofovir + emtricitabine, lopinavir/ritonavir | Phase 2 |
The Los Angeles County P-QUAD program is a combined effort of County, City, public health, community, academic, and private agencies and individuals in an effort to provide a comprehensive package of HIV prevention services of which PEP can be an integral component. These services are designed to be easily accessible, non-judgmental, culturally, ethnically, and linguistically appropriate to the relevant populations, community-based, and independent of ability to pay or insurance/documentation status. They will also provide vital linkages to associated services, routine HIV testing, and primary health care.
In its initial pilot project, 2 community-based sites will serve as facilities at which patients may present for screening for post-exposure prophylaxis services, as well as sexually transmitted diseases. At the sites, initial eligibility and testing will be performed, and an initial 14-day supply of PEP medications will be provided if appropriate, and referrals will be initiated. All subjects who are provided an initial 14-day supply will be required to return to the site for the remainder of the 28-day course of medication, follow-up testing, adherence counseling, risk-reduction programming, and other appropriate referrals. Follow-up with patients by phone, email, and mobile-phone text message will be used as appropriate to maximize program retention.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 267 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | A Pilot Project to Operationalize the Prevention Strategy of Post Exposure Prophylaxis Following Sexual Exposure to HIV in Combination With Educational Programming and Behavioral Risk Reduction Strategies in Los Angeles County |
| Study Start Date : | March 2010 |
| Actual Primary Completion Date : | June 2010 |
| Actual Study Completion Date : | August 2011 |
| Arm | Intervention/treatment |
|---|---|
|
Open-Label
This was an open-label demonstration project. Therefore, medications were not blinded and participants were made aware of the regimen they received for PEP.
|
Drug: tenofovir + emtricitabine, lopinavir/ritonavir
The preferred regimen will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a creatinine clearance 30-49 mL/min, dosing of Truvada is 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min or on hemodialysis, Truvada should not be used. For intolerance to Truvada, Combivir (zidovudine 300mg/lamivudine 150mg)will be available to be taken as 1 PO BID. For highest-risk category exposures (receptive anal intercourse with a known or suspected HIV-positive source patient or in cases of suspected source drug resistance, see Schema, below) one of the following should be added to the above "standard" treatment, creating an "expanded" regimen: Preferred: Lopinavir/ritonavir (200mg/50mg), 2 tablets orally twice daily or 4 tablets once daily Other Names:
|
- Retention, Measured as the Number of HIV Exposure Events That Were Retained in Care at the 24 Week Follow-up Visit [ Time Frame: 24 Weeks ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 <18 years of age
- Unable to understand and provide consent
- Exposure >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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00949234
| United States, California | |
| L.A. Gay & Lesbian Center | |
| Los Angeles, California, United States, 90028 | |
| OASIS Clinic | |
| Los Angeles, California, United States, 90059 | |
| Principal Investigator: | Raphael J. Landovitz, M.D. | University of California, Los Angeles |
| Responsible Party: | Dr. Raphael Landovitz, Associate Director, UCLA Center for Clinical AIDS Research & Education (CARE), University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT00949234 History of Changes |
| Other Study ID Numbers: |
PQUAD |
| First Posted: | July 30, 2009 Key Record Dates |
| Results First Posted: | December 18, 2017 |
| Last Update Posted: | December 18, 2017 |
| Last Verified: | December 2017 |
Keywords provided by Dr. Raphael Landovitz, University of California, Los Angeles:
|
post exposure prophylaxis biomedical prevention HIV seronegativity |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Lopinavir Tenofovir Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
Lamivudine, zidovudine drug combination HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |