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A Pilot Study of Pre-Exposure Prophylaxis (PrEP) to Evaluate Safety, Acceptability, and Adherence in At-Risk Populations in Kenya, Africa

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. Identifier: NCT00971230
Recruitment Status : Completed
First Posted : September 3, 2009
Last Update Posted : August 9, 2010
Information provided by:
International AIDS Vaccine Initiative

Tracking Information
First Submitted Date  ICMJE September 2, 2009
First Posted Date  ICMJE September 3, 2009
Last Update Posted Date August 9, 2010
Study Start Date  ICMJE October 2009
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2009)
  • Safety and tolerability: The proportion of volunteers with moderate and greater severity clinical adverse events; mild, moderate and greater severity of renal toxicities, and other moderate and severe laboratory abnormalities. [ Time Frame: 6 months ]
  • Acceptability: The proportion of volunteers who report willingness to use the study regimen [ Time Frame: 6 months ]
  • Intracellular drug concentrations: The mean intracellular drug concentration for each group assigned to FTC/TDF [ Time Frame: 6 months ]
  • Adherence: Proportion of volunteers who took, by MEMS data, at least 80% of expected doses of the IP; Proportion of volunteers assigned to FTC/TDF who have detectable drug plasma levels within 48 hrs of use. [ Time Frame: 6 months ]
  • Behavioral: Reported number of steady and casual sex partners; Frequency of unprotected vaginal and/or anal intercourse; Substance use prior to or during sex [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2009)
  • Proportion of volunteers who report somewhat high or high levels of burden in using electronic medication monitoring to measure adherence, and using cell phone communication to measure sexual activity [ Time Frame: 6 months ]
  • The proportion of study days with missing SMS sexual activity data [ Time Frame: 6 months ]
  • The proportion of volunteers who report sharing medications [ Time Frame: 6 months ]
  • The proportion of volunteers assigned to placebo who have detectable intracellular drug levels [ Time Frame: 6 months ]
  • The proportion of volunteers with HIV-specific immune responses as measured by analysis of cellular or humoral immune response, or changes in gene regulation as measured by microarray or proteomic techniques [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Pilot Study of Pre-Exposure Prophylaxis (PrEP) to Evaluate Safety, Acceptability, and Adherence in At-Risk Populations in Kenya, Africa
Official Title  ICMJE A Pilot Study of Pre-Exposure Prophylaxis (PrEP) to Evaluate Safety, Acceptability, and Adherence in At-risk Populations in Kenya, Africa
Brief Summary

This study will evaluate the safety and acceptability of an intermittent and daily PrEP regimen using Tenofovir Disoproxil Fumarate plus Emtricitabine (FTC/TDF) in men and women at risk for HIV, and it will directly compare adherence and intracellular drug levels in daily and intermittent PrEP recipients. It will also evaluate the relationship between drug adherence, sexual behavior and intracellular drug levels with an intermittent PrEP regimen. In addition it will evaluate the relationship between adherence to an intermittent PrEP regimen and timing of sexual activity in relation to PrEP dosing. The study will use objective medication event monitoring medication event monitors (MEMS) adherence measurement and evaluate the feasibility of newer adherence measurements such as hair sampling and plasma drug levels. The study will also evaluate the feasibility of using SMS (text messages) to collect sexual activity data in an African setting. It will allow study teams and communities to prepare for potential subsequent larger trials of intermittent PrEP. This study is not sized to evaluate efficacy. If the intermittent PrEP regimen is shown to be safe, feasible in terms of adherence, and achieves intracellular drug levels similar to daily PrEP, these data could be used to design a larger phase 2 study with one or more intermittent PrEP regimens. The goal of such a trial would be to provide bridging data if daily PrEP regimens are found to be effective or to prepare for efficacy or non-inferiority trials of intermittent versus daily PrEP.

Investigation of immune responses associated with FTC/TDF will also be evaluated in the pilot study. The proportion of volunteers on FTC/TDF with HIV-specific immune responses, due to exposures that did not lead to established HIV infection, will be assessed at 2-3 time points and compared to responses in volunteers assigned to placebo. Immune responses may be correlated with risk behavior and host factors, such as human leukocyte antigen (HLA) type. As noted above, very few HIV infections are expected to occur during the study, so correlation of HIV-specific immune responses and protection from infection or attenuation of disease progression will not be possible until a larger study is conducted.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • Drug: FTC/TDF
    emtricitabine/tenofovir disoproxil fumarate
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: FTC/TDF- Daily
    FTC/TDF dosed daily
    Intervention: Drug: FTC/TDF
  • Experimental: FTC/TDF-Intermittent
    FTC/TDF dosed intermittently
    Intervention: Drug: FTC/TDF
  • Placebo Comparator: Placebo-Daily
    Placebo dosed daily
    Intervention: Drug: Placebo
  • Placebo Comparator: Placebo-Intermittent
    Placebo dosed intermittently
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 2, 2009)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study
  • Has understood the information provided and has provided written informed consent before any study-related procedures are performed
  • Willing to undergo HIV testing, STI screening, HIV counselling and receive HIV and STI test results
  • At risk for HIV infection as defined by at least one of the following:

    • Current sexually-transmitted infection (STI) or STI in the previous 3 months
    • In the past 3 months had multiple episodes of unprotected vaginal sex
    • In the past 3 months had multiple episodes of unprotected anal sex
    • In the past 3 months engaged in sex work for money or drugs
  • If a female of childbearing potential (i.e., not post-menopausal or surgically sterile), using an effective method of non-barrier contraception (hormonal contraceptive; intrauterine device (IUD); surgical sterility) from 7 days prior to randomization until the end of the study. All female volunteers must be willing to undergo urine pregnancy tests

Exclusion Criteria

  • Confirmed HIV-1 or HIV-2 infection
  • Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the investigator would make the volunteer unsuitable for the study, including severe infections requiring treatment such as tuberculosis, and alcohol or drug abuse
  • Any of the following abnormal laboratory parameters:

    • Haemoglobin <9.0 g/dL
    • Creatinine clearance <80mL/min, as calculated by Cockcroft-Gault equation
    • AST: >2.5 x ULN
    • ALT: >2.5 x ULN
    • Total bilirubin >1.5 x ULN
    • Serum amylase >1.5 x ULN
    • Serum phosphorus <2.4 mg/dL
    • Urinalysis: Two abnormal dipsticks showing any of the following:

      • blood = 2+ or more (not due to menses)
      • protein = 1+ or more
      • leucocytes = 2+ or more
      • glucose= 1+ or more
  • Confirmed diagnosis of chronic hepatitis B infection (HBsAg positive)
  • If female, pregnant or planning a pregnancy within 4 months after enrolment or lactating
  • Participation in another clinical study of an investigational product currently, within the 3 months prior to enrolment or expected participation during this study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kenya
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00971230
Other Study ID Numbers  ICMJE IAVI E001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Patricia Fast MD PhD, Chief Medical Officer, International AIDS Vaccine Initiative
Study Sponsor  ICMJE International AIDS Vaccine Initiative
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gaudensia Mutua, MB.ChB, MPH Kenya AIDS Vaccine Initiative, University of Nairobi
Principal Investigator: E.J. Sanders, MD, MPH, PhD Kenya Medical Research Institute, Center for Geographic Medicine Research - Coast
Study Chair: Omu Anzala, MB.ChB, Phd Kenya AIDS Vaccine Initiative, University of Nairobi
PRS Account International AIDS Vaccine Initiative
Verification Date August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP