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Interventions for HIV Negative Men and Women Who Have High-risk Suspected Exposure to HIV

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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
PEP Group 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.

Participant Flow:   Overall Study
    PEP Group
STARTED   267 
COMPLETED   225 
NOT COMPLETED   42 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
PEP Group 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.

Baseline Measures
   PEP Group 
Overall Participants Analyzed 
[Units: Participants]
 267 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      266  99.6% 
>=65 years      1   0.4% 
Age 
[Units: Years]
Median (Full Range)
 32 
 (19 to 66) 
Sex/Gender, Customized 
[Units: Participants]
 
Male   253 
Female   11 
Transgender   3 
Race/Ethnicity, Customized 
[Units: Participants]
 
Black/AA   23 
White   128 
Hispanic/Latino(a)   92 
Asian   13 
American Indian/Alaska Native   1 
Other   10 
Region of Enrollment 
[Units: Participants]
 
United States   267 


  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Open label clinical trial of deploying PEP regimens at community based sites. Non-randomized and guidelines have subsequently evolved.


  More Information

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
e-mail: rlandovitz@mednet.ucla.edu



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