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HIV InfectionsPhase 1/2NCT00971230

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

A Phase 1/2 study testing FTC/TDF in people with HIV Infections, run by International AIDS Vaccine Initiative at 2 sites in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
FTC/TDF
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
2 sitesKenya
Study dates
Oct 2009to Jul 2010
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

2 sites in 1 country.

Kenya2 sites

  • Kenya Medical Research Institute, Center for Geographic Medicine Research - Coast

    Kilifi, Kilifi County

  • Kenya AIDS Vaccine Initiative, University of Nairobi

    Nairobi, Nairobi County

Other trials in Kenya

About this study

Official title: 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.

Conditions
HIV Infections
Being tested
FTC/TDF, Placebo
Keywords
HIV, Human Immunodeficiency Virus
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FTC/TDFDrug

    emtricitabine/tenofovir disoproxil fumarate

  • PlaceboDrug

    Placebo

Study groups in NCT00971230
Study groupRoleWhat they receive
FTC/TDF- DailyExperimentalFTC/TDF dosed daily
Receives: Drug: FTC/TDF
FTC/TDF-IntermittentExperimentalFTC/TDF dosed intermittently
Receives: Drug: FTC/TDF
Placebo-DailyPlacebo comparatorPlacebo dosed daily
Receives: Drug: Placebo
Placebo-IntermittentPlacebo comparatorPlacebo dosed intermittently
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

  2. Acceptability: The proportion of volunteers who report willingness to use the study regimen

    Measured: 6 months

  3. Intracellular drug concentrations: The mean intracellular drug concentration for each group assigned to FTC/TDF

    Measured: 6 months

  4. 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.

    Measured: 6 months

  5. Behavioral: Reported number of steady and casual sex partners; Frequency of unprotected vaginal and/or anal intercourse; Substance use prior to or during sex

    Measured: 6 months

Secondary outcomes (5)

  1. 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

    Measured: 6 months

  2. The proportion of study days with missing SMS sexual activity data

    Measured: 6 months

  3. The proportion of volunteers who report sharing medications

    Measured: 6 months

  4. The proportion of volunteers assigned to placebo who have detectable intracellular drug levels

    Measured: 6 months

  5. 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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionJun 2010
  4. Study completionJul 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00971230
Sponsor's protocol ID
IAVI E001
Status last verified
Aug 2010
First submitted
2 Sep 2009
Last updated
9 Aug 2010
Results posted
No

Publications

  • Baxi SM, Liu A, Bacchetti P, Mutua G, Sanders EJ, Kibengo FM, Haberer JE, Rooney J, Hendrix CW, Anderson PL, Huang Y, Priddy F, Gandhi M. Comparing the novel method of assessing PrEP adherence/exposure using hair samples to other pharmacologic and traditional measures. J Acquir Immune Defic Syndr. 2015 Jan 1;68(1):13-20. doi: 10.1097/QAI.0000000000000386.

    PubMed 25296098

  • Mutua G, Sanders E, Mugo P, Anzala O, Haberer JE, Bangsberg D, Barin B, Rooney JF, Mark D, Chetty P, Fast P, Priddy FH. Safety and adherence to intermittent pre-exposure prophylaxis (PrEP) for HIV-1 in African men who have sex with men and female sex workers. PLoS One. 2012;7(4):e33103. doi: 10.1371/journal.pone.0033103. Epub 2012 Apr 12.

    PubMed 22511916

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing FTC/TDF in people with HIV Infections, run by International AIDS Vaccine Initiative at 2 sites in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00971230, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2010.

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