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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

5 augusti 2010 uppdaterad av: International AIDS Vaccine Initiative

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

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Förväntat)

72

Fas

  • Fas 2
  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Kenya
      • Kilifi, Kenya
        • Kenya Medical Research Institute, Center for Geographic Medicine Research - Coast
      • Nairobi, Kenya
        • Kenya AIDS Vaccine Initiative, University of Nairobi

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 49 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: FTC/TDF- Daily
FTC/TDF dosed daily
Läkemedel: FTC/TDF
emtricitabine/tenofovir disoproxil fumarate
Experimentell: FTC/TDF-Intermittent
FTC/TDF dosed intermittently
Läkemedel: FTC/TDF
emtricitabine/tenofovir disoproxil fumarate
Placebo-jämförare: Placebo-Daily
Placebo dosed daily
Läkemedel: Placebo
Placebo
Placebo-jämförare: Placebo-Intermittent
Placebo dosed intermittently
Läkemedel: Placebo
Placebo

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
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.
Tidsram: 6 months
6 months
Acceptability: The proportion of volunteers who report willingness to use the study regimen
Tidsram: 6 months
6 months
Intracellular drug concentrations: The mean intracellular drug concentration for each group assigned to FTC/TDF
Tidsram: 6 months
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.
Tidsram: 6 months
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
Tidsram: 6 months
6 months

Sekundära resultatmått

Resultatmått
Tidsram
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
Tidsram: 6 months
6 months
The proportion of study days with missing SMS sexual activity data
Tidsram: 6 months
6 months
The proportion of volunteers who report sharing medications
Tidsram: 6 months
6 months
The proportion of volunteers assigned to placebo who have detectable intracellular drug levels
Tidsram: 6 months
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
Tidsram: 6 months
6 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

International AIDS Vaccine Initiative

Utredare

  • Huvudutredare: Gaudensia Mutua, MB.ChB, MPH, Kenya AIDS Vaccine Initiative, University of Nairobi
  • Huvudutredare: E.J. Sanders, MD, MPH, PhD, Kenya Medical Research Institute, Center for Geographic Medicine Research - Coast
  • Studiestol: Omu Anzala, MB.ChB, Phd, Kenya AIDS Vaccine Initiative, University of Nairobi

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2009

Primärt slutförande (Faktisk)

1 juni 2010

Avslutad studie (Faktisk)

1 juli 2010

Studieregistreringsdatum

Först inskickad

2 september 2009

Först inskickad som uppfyllde QC-kriterierna

2 september 2009

Första postat (Uppskatta)

3 september 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

9 augusti 2010

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 augusti 2010

Senast verifierad

1 augusti 2010

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • IAVI E001

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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