ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Collaborators:
Los Angeles County Department of Public Health
AIDS Project Los Angeles
Los Angeles LGBT Center
The OASIS Clinic
Information provided by (Responsible Party):
Dr. Raphael Landovitz, University of California, Los Angeles

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions HIV Prevention
HIV Infections
Intervention Drug: tenofovir + emtricitabine, lopinavir/ritonavir
Enrollment 267
Recruitment Details Two community-based sites, Jeffrey Goodman Clinic and The OASIS Clinic, will serve as facilities at which participants may present for screening for post-exposure prophylaxis services, as well as sexually transmitted diseases.
Pre-assignment Details  
Arm/Group Title PEP Group
Hide Arm/Group Description An intake of inclusion and exclusion criteria will be performed by program personnel. HIV-testing and STI testing will be provided as well as a brief and directed history and physical examination. If all inclusion and no exclusion criteria are met, an initial dose of PEP medications will be provided for immediate ingestion. A 14-day supply of PEP medications will be provided. Participant information sheets regarding PEP will be provided. Initial safety laboratory measurements and assessment of necessary referral services will be made, and behavioral risk assessment will stratify participants into “moderate behavioral risk,” or “high behavioral risk.” Moderate risk participants will receive risk-reduction programming within the P-QUAD program; high-risk participants will be referred externally to existing LA County behavioral risk-reduction programming.
Period Title: Overall Study
Started 267
Completed 225
Not Completed 42
Arm/Group Title PEP Group
Hide Arm/Group Description An intake of inclusion and exclusion criteria will be performed by program personnel. HIV-testing and STI testing will be provided as well as a brief and directed history and physical examination. If all inclusion and no exclusion criteria are met, an initial dose of PEP medications will be provided for immediate ingestion. A 14-day supply of PEP medications will be provided. Participant information sheets regarding PEP will be provided. Initial safety laboratory measurements and assessment of necessary referral services will be made, and behavioral risk assessment will stratify participants into “moderate behavioral risk,” or “high behavioral risk.” Moderate risk participants will receive risk-reduction programming within the P-QUAD program; high-risk participants will be referred externally to existing LA County behavioral risk-reduction programming.
Overall Number of Baseline Participants 267
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 267 participants
<=18 years
0
   0.0%
Between 18 and 65 years
266
  99.6%
>=65 years
1
   0.4%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 267 participants
32
(19 to 66)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 267 participants
Male 253
Female 11
Transgender 3
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 267 participants
Black/AA 23
White 128
Hispanic/Latino(a) 92
Asian 13
American Indian/Alaska Native 1
Other 10
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 267 participants
267
1.Primary Outcome
Title Retention, Measured as the Number of HIV Exposure Events That Were Retained in Care at the 24 Week Follow-up Visit
Hide Description [Not Specified]
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
254 individuals were exposed to HIV once and received PEP; 11 individuals were exposed to HIV twice and received a PEP regimen twice; and 2 were exposed to HIV three times and received a PEP regimen for each of the three exposures
Arm/Group Title PEP Group
Hide Arm/Group Description:
An intake of inclusion and exclusion criteria will be performed by program personnel. HIV-testing and STI testing will be provided as well as a brief and directed history and physical examination. If all inclusion and no exclusion criteria are met, an initial dose of PEP medications will be provided for immediate ingestion. A 14-day supply of PEP medications will be provided. Participant information sheets regarding PEP will be provided. Initial safety laboratory measurements and assessment of necessary referral services will be made, and behavioral risk assessment will stratify participants into “moderate behavioral risk,” or “high behavioral risk.” Moderate risk participants will receive risk-reduction programming within the P-QUAD program; high-risk participants will be referred externally to existing LA County behavioral risk-reduction programming.
Overall Number of Participants Analyzed 267
Overall Number of Units Analyzed
Type of Units Analyzed: HIV Exposure Events
282
Count of Units
Unit of Measure: HIV Exposure Events
Retained at 24 Weeks
125
  44.3%
Not Retained at 24 Weeks
157
  55.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEP Group
Comments There was no power calculation for this analysis. The study was mainly descriptive, but Chi-square tests were used to determine if there were differences between individuals who were retained at the 24 Week Follow-up visit from individuals who were not retained at the 24 Week Follow-up visit.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame 24 Weeks
Adverse Event Reporting Description Some individuals reenrolled in the study if an HIV exposure occurred at a later date. 254 individuals were exposed to HIV once and received PEP; 11 individuals were exposed to HIV twice and received a PEP regimen twice; and 2 were exposed to HIV three times and received a PEP regimen for each of the three exposures. A total of 282 PEP regimens were initiated on 267 unique individuals. 282 was used as the denominator for report Adverse Events.
 
Arm/Group Title PEP Group
Hide Arm/Group Description An intake of inclusion and exclusion criteria will be performed by program personnel. HIV-testing and STI testing will be provided as well as a brief and directed history and physical examination. If all inclusion and no exclusion criteria are met, an initial dose of PEP medications will be provided for immediate ingestion. A 14-day supply of PEP medications will be provided. Participant information sheets regarding PEP will be provided. Initial safety laboratory measurements and assessment of necessary referral services will be made, and behavioral risk assessment will stratify participants into “moderate behavioral risk,” or “high behavioral risk.” Moderate risk participants will receive risk-reduction programming within the P-QUAD program; high-risk participants will be referred externally to existing LA County behavioral risk-reduction programming.
All-Cause Mortality
PEP Group
Affected / at Risk (%)
Total   0/282 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
PEP Group
Affected / at Risk (%)
Total   0/282 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PEP Group
Affected / at Risk (%)
Total   155/282 (54.96%) 
Gastrointestinal disorders   
Diarrhea   78/282 (27.66%) 
Nausea  48/282 (17.02%) 
Mild to moderate abdominal discomfort  24/282 (8.51%) 
General disorders   
Fatigue  39/282 (13.83%) 
Indicates events were collected by systematic assessment
Open label clinical trial of deploying PEP regimens at community based sites. Non-randomized and guidelines have subsequently evolved.
Certain Agreements
Principal Investigators are NOT 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. Raphael Landovitz
Organization: UCLA CARE Center
Phone: 310-557-1891
Responsible Party: Dr. Raphael Landovitz, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00949234     History of Changes
Other Study ID Numbers: PQUAD
First Submitted: July 29, 2009
First Posted: July 30, 2009
Results First Submitted: October 2, 2017
Results First Posted: December 18, 2017
Last Update Posted: December 18, 2017