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HIV InfectionPhase 1/2NCT00931346

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

A Phase 1/2 study testing FTC/TDF in people with HIV Infection, run by International AIDS Vaccine Initiative at 1 site in Uganda.

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 intermittent and daily pre-exposure prophylaxis (PrEP) regimens with FTC/TDF (emtricitabine/tenofovir disoproxil fumarate) in HIV discordant couples, 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 Infection
What is being tested?
FTC/TDF
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
1 siteUganda
Study dates
Oct 2009to Oct 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 protocol and available for follow-up for the study duration
  • Has understood the information provided and has provided written informed consent before any study-related procedures are performed
  • Willing to undergo couple HIV testing, sexually transmitted infection (STI) screening, HIV counseling and receive test results, and share results with partner
  • At risk for HIV infection as defined by: has an HIV-infected partner not using ART in the past 3 months and had episodes of unprotected sex with partner in the past 3 months
  • If a female of childbearing potential:
  • using an effective method of non-barrier contraception (hormonal contraceptive
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  • 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
  • HIV-infected partner is willing and eligible to enroll in the study
  • HIV-1 infected partner of an HIV-uninfected volunteer who meets study eligibility
  • Plan to remain in the relationship for the duration of the study period
  • Willing and able to provide written informed consent \& locator information

Who cannot join

  • Confirmed HIV-1 or HIV-2 infection
  • Any clinically significant acute or chronic medical condition that is considered progressive, including severe infections requiring treatment such as tuberculosis, and alcohol or drug abuse
  • Any of the following abnormal lab 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 a product currently, or within the 3 mo. prior to enrolment
  • Current use of antiretroviral therapy
  • Concurrent enrollment in another HIV treatment trial

Trial locations and contacts

1 site in 1 country.

Uganda1 site

  • MRC-Entebbe

    Entebbe, Entebbe

Other trials in Uganda

About this study

This study will evaluate the safety and acceptability of intermittent and daily pre-exposure prophylaxis (PrEP) regimens with FTC/TDF (emtricitabine/tenofovir disoproxil fumarate) in HIV discordant couples, 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 pilot will use objective medication event monitoring (MEMS) adherence measurement and evaluate the feasibility of newer adherence measurements such as hair sampling and plasma drug levels. This study will also evaluate the feasibility of using text messaging (SMS) 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. The study is not sized to evaluate efficacy. If the intermittent PrEP regimen is safe, feasible in terms of adherence, and achieves intracellular drug levels similar to daily PrEP, the data could be used to design a larger phase 2 study with one or more intermittent PrEP regimens. The goal of such a larger 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 Infection
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 NCT00931346
Study groupRoleWhat they receive
FTC/TDF DailyExperimentalDaily dosing
Receives: Drug: FTC/TDF
FTC/TDF IntermittentExperimentalDosed intermittently
Receives: Drug: FTC/TDF
Placebo DailyPlacebo comparatorPlacebo dosed daily
Receives: Drug: Placebo
Placebo IntermittentPlacebo comparatorPlacebo dosed intermittently, orally.
Receives: Drug: Placebo

What is being measured

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

  1. Safety and tolerability: volunteers with moderate and greater severity clinical adverse events, renal toxicities, and other moderate and severe laboratory abnormalities.

    Measured: 6 months

  2. Acceptability: proportion of volunteers who report willingness to use the study regimen; the acceptability to the HIV-infected partner of their partner using the investigational product

    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 vol. who took, by MEMS data, at least 80% of doses; vol. assigned to FTC/TDF with detectable drug plasma levels within 48 hrs of use; relationship between intracellular drug levels and adherence in vol. assigned to FTC/TDF

    Measured: 6 months

  5. Behavioral: reported number of steady and casual sex partners; frequency of unprotected vaginal intercourse; substance use prior to or during sex

    Measured: 6 months

Secondary outcomes (6)

  1. The 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 assigned to placebo who have detectable intracellular drug levels

    Measured: 6 months

  4. The proportion of HIV-infected partners in discordant couples not on ART with detectable 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

  6. The proportion of volunteers who report sharing medications

    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 posted2 Jul 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionOct 2010
  4. Study completionOct 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
NCT00931346
Sponsor's protocol ID
IAVI E002
Status last verified
Aug 2011
First submitted
29 Jun 2009
Last updated
25 Aug 2011
Results posted
No
Data monitoring committee
Yes

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

  • Kibengo FM, Ruzagira E, Katende D, Bwanika AN, Bahemuka U, Haberer JE, Bangsberg DR, Barin B, Rooney JF, Mark D, Chetty P, Fast P, Kamali A, Priddy FH. Safety, adherence and acceptability of intermittent tenofovir/emtricitabine as HIV pre-exposure prophylaxis (PrEP) among HIV-uninfected Ugandan volunteers living in HIV-serodiscordant relationships: a randomized, clinical trial. PLoS One. 2013 Sep 26;8(9):e74314. doi: 10.1371/journal.pone.0074314. eCollection 2013.

    PubMed 24086333

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing FTC/TDF in people with HIV Infection, run by International AIDS Vaccine Initiative at 1 site in Uganda.

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 13 inclusion and 20 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 25 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Uganda. 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: volunteers with moderate and greater severity clinical adverse events, 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 NCT00931346, 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 25 Aug 2011.

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