FEM-PrEP (Truvada®): Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women

A Phase 3 study testing Truvada in people with HIV Infections, run by FHI 360 at 4 sites in 3 countries.

Completed

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

Trial summary

This Phase III, double-blind, randomized, placebo-controlled trial enrolled HIV-negative women from 4 sites in 3 countries (Kenya, Tanzania, South Africa). The study's purpose was to investigate the safety and effectiveness of a once-daily Truvada® pill (compared with placebo) in preventing HIV among HIV-uninfected… Read more about this study

Who is it for?: Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for: HIV Infections
What is being tested?: Truvada
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2,120 participants
Where: 4 sitesin 3 countries
Study dates: May 2009to Jan 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 35 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Willing and able (see criterion 2) to provide written informed consent to be screened for and to participate in the trial
Able to answer a percentage of informed consent screening (75%) and enrollment (100%) comprehension quiz questions correctly
Between 18-35 years old, inclusive
At higher risk of becoming HIV infected
Have a final negative result according to the site-specific screening HIV testing algorithm and a final negative result at enrollment according to the study HIV testing algorithm
Willing to participate in all aspects of the study and to comply with study procedures, for up to 60 weeks, including:

Show all 26Show fewer

Be randomized
Use study product as directed
Adhere to follow-up schedule and willing to be contacted by site staff between study visits (by phone and/or in person)
Use a study-approved effective non-barrier method of contraception for the duration of the study
Take study product, as evidenced by swallowing a vitamin tablet that is similar in size to the study product at enrollment
Provide contact information and agrees to some form of contact method throughout the study
Not intending to relocate out of the area for the duration of the study participation and does not have a job or other obligations that may require long absences from the area ( > 1 month at a time)
In general good health and have no condition (social or medical) which, in the opinion of the Site Investigator, would make study participation unsafe or complicate data interpretation
Not pregnant or breastfeeding, and does not anticipate a desire for pregnancy during the 52 weeks of on-product participation
Medically eligible at screening including:
Adequate renal function (serum creatinine ≤ upper limit of normal (ULN) of local range and creatinine clearance ≥ 60ml/min estimated by the Cockcroft-Gault Creatinine Clearance Formula
Adequate hepatic function (hepatic transaminases ALT and AST < 2x ULN [according to local normal ranges])
HBsAg negative
Serum phosphorus levels above the lower limit of the local normal range (according to local normal ranges - grade 3 \& 4 hypophosphatemia will be excluded even if within normal local ranges)
Not received or receiving an experimental HIV vaccine, participating in another HIV prevention study or participating in any other clinical trial with a biomedical intervention
No clinical signs of liver disease (e.g., ascites, spider angiomata, hepatomegaly, jaundice)
No definite evidence of glycosuria or proteinuria (i.e., no repeated positive [ ≥ + 1 ] urine dipstick). If a urine dipstick is positive for either glucose and/or protein at the first test, a second urine sample will be tested.
No history of pathological bone fractures
No history of adverse reaction to latex
Not taking any of the following medications: nephrotoxic agents; aminoglycoside antibiotics (including gentamicin); intravenous (IV) amphotericin B; cidofovir; cisplatin; foscarnet; IV pentamidine; oral or IV vancomycin; oral or IV gancyclovir; other agents with significant nephrotoxic potential; drugs that slow renal excretion; probenecid; immune system modulators; systemic chemotherapeutic agents (i.e. cancer treatment medications); systemic corticosteroids; interleukin-2 (IL-2); immunomodulators; interferon (alpha, beta, or gamma); other antiretrovirals (including nucleoside analogs, non-nucleoside reverse transcriptase inhibitors, protease inhibitors or investigational antiretroviral agents)

Who cannot join

None listed.

Trial locations and contacts

4 sites in 3 countries.

Country

City, postcode or hospital

4 sites in 3 countries

South Africa2 sites

Josha Research Center
Bloemfontein
Setshaba Research Centre
Pretoria, Gauteng

Other trials in South Africa

Kenya1 site

Bondo Clinic, Bondo District Hospital
Bondo, Nyanza

Other trials in Kenya

Tanzania1 site

Arusha Clinic, Levolosi Health Center
Arusha

Other trials in Tanzania

About this study

Official title: Phase 3, Multi-center, Double-blind, Randomized, Placebo-controlled Effectiveness and Safety Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women

After enrollment, each participant was followed every four weeks. All participants were followed for an additional eight weeks after study drug was stopped. Incidence rates of HIV infection were compared between the two groups (active drug and placebo) using the intent-to-treat principle.

Read the detailed description

The study population included HIV-antibody-negative women between the ages of 18-35 who were at risk of HIV acquisition through sexual intercourse. Each participant was randomized to take either a daily single oral tablet of Truvada®, which is a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg), or an identical placebo. All participants received risk reduction counseling and condoms. Women had to be using a study-approved effective non-barrier contraceptive method at the time of enrollment and were asked to do so for the whole period they were on study drug. They received contraceptive counseling throughout the study. Any diagnosed, treatable sexually transmitted infection was treated free of charge.

After enrollment, each participant was followed every four weeks. All participants were followed for an additional eight weeks after study drug was stopped. Participants at risk for Hepatitis B Virus (HBV) flare were followed every four weeks for 12 weeks after stopping study product. Participants who acquired HIV infection during the study stopped taking the study drug at the time of HIV diagnosis, and will be followed for 52 weeks post diagnosis and were referred for care and treatment. Participants who became pregnant stopped taking the study drug but continued follow-up visits. Incidence rates of HIV infection were compared between the two groups (active drug and placebo) using the intent-to-treat principle.

Conditions: HIV Infections
Being tested: Truvada, Placebo
Keywords: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), HIV, HIV Prevention, Oral PrEP, Truvada, women, Tenofovir, TDF, FTC, emtricitabine, hepatitis, Pre-exposure Prophylaxis (PrEP), HIV Seronegativity
Medical subject headings: HIV Infections, Hepatitis

What participants receive

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

TruvadaDrug
Also called TDF/FTC - emtricitabine and tenofovir disoproxil fumarate
Daily single oral tablet of Truvada - a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
PlaceboOther
Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.

Study groups in NCT00625404
Study group	Role	What they receive
Truvada Arm	Experimental	Daily single oral tablet of Truvada (TDF/FTC), a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg). Receives: Drug: Truvada
Placebo Arm	Placebo comparator	Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients. Receives: Other: Placebo

What is being measured

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

HIV Infection
HIV Seroconversion, with time to infection refined based on PCR results obtained from stored specimens.
Measured: Cumulative HIV infection between enrollment and 52 weeks
Confirmed Grade 2 or Higher Serum Creatinine Toxicity
Repeat specimens were collected to confirm chemistry toxicities. Grade 2 or higher serum creatinine toxicity was defined as ≥1.4 times the upper limit of normal
Measured: cumulative toxicity through 52 weeks of product use and 4 weeks post product
Frequency of Adverse Events (AEs) During and Within 4 Weeks After Study Product Administration
The total number of adverse events in the placebo and Truvada arms during and within 4 weeks after study product administration.
Measured: 10-26 months per site
Confirmed Grade 3 or Higher Reduction in Phosphorus
Repeat specimens were collected to confirm chemistry toxicities. Grade 3 phosphorus reduction was defined as ≤2.4mg/dL
Measured: Through 52 weeks on product and 4 weeks post-product
Confirmed Grade 3 or Higher ALT Elevation
Grade 3 or higher ALT elevation was defined as ≥ 2.6 times the upper limit of normal
Measured: Through 52 weeks on product and 4 weeks post-product
Confirmed Grade 3 or Higher AST Elevation
Grade 3 or higher AST elevation was defined as ≥ 2.6 times the upper limit of normal
Measured: Through 52 weeks on product and 4 weeks post-product

Secondary outcomes (6)

Plasma HIV RNA Level (HIV-1 Viral Load)
Viral load at the time of HIV detection, HIV conversion and through 16 weeks
Measured: up to 16 weeks
CD4+ T-cell Count
CD4+ T-cell Count at the Time of HIV Seroconversion through 16 weeks
Measured: Up to 16 weeks
FTC and/or Tenofovir Resistance
Genotypic resistance to FTC and/or tenofovir at the time of HIV diagnosis and 4 weeks later. If resistance was present, testing was repeated at weeks 12, 24, 36 and 52 as necessary (resistance testing will stop if no resistance is detected).
participants were classified as having resistance if they had one or more visits in which resistance was detected, even if the resistance became undetectable over time.
Measured: up to 52 weeks
Pregnancy Complications
Reported complications during pregnancy, including spontaneous abortion, vaginal or uterine bleeding, emergency c-section and other complications
Measured: up to 60 weeks
Pill Counts and Participant Report of Adherence to Once-daily Pill Taking
Pill counts and participant report of adherence to once-daily pill taking reported as mean days study product could have been used according to pill counts
Measured: Up to 52 weeks
Participant Report of Change in Number of Sexual Partners
Difference in mean number of reported sexual partners between final study visit and enrollment visit
Measured: Up to 52 weeks

Timeline

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

May 2009Jan 2013

First posted28 Feb 2008 (estimated)
Study startMay 2009
Primary completionAug 2012
Study completionJan 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 2,120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00625404
Sponsor's protocol ID: 10015
Status last verified: Jun 2018
First submitted: 19 Feb 2008
Last updated: 26 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Lut Van Damme, M.D., Amy Corneli, Ph.D. and Douglas Taylor, Ph.D. New England Journal of Medicine 367: 411-422, 2012
Mandala J, Nanda K, Wang M, De Baetselier I, Deese J, Lombaard J, Owino F, Malahleha M, Manongi R, Taylor D, Van Damme L. Liver and renal safety of tenofovir disoproxil fumarate in combination with emtricitabine among African women in a pre-exposure prophylaxis trial. BMC Pharmacol Toxicol. 2014 Dec 24;15:77. doi: 10.1186/2050-6511-15-77.
PubMed 25539648
Grant RM, Liegler T, Defechereux P, Kashuba AD, Taylor D, Abdel-Mohsen M, Deese J, Fransen K, De Baetselier I, Crucitti T, Bentley G, Agingu W, Ahmed K, Damme LV. Drug resistance and plasma viral RNA level after ineffective use of oral pre-exposure prophylaxis in women. AIDS. 2015 Jan 28;29(3):331-7. doi: 10.1097/QAD.0000000000000556.
PubMed 25503265
Todd CS, Deese J, Wang M, Hubacher D, Steiner MJ, Otunga S, Van Damme L; FEM-PrEP Study Group. Sino-implant (II)(R) continuation and effect of concomitant tenofovir disoproxil fumarate-emtricitabine use on plasma levonorgestrel concentrations among women in Bondo, Kenya. Contraception. 2015 Mar;91(3):248-52. doi: 10.1016/j.contraception.2014.10.008. Epub 2014 Oct 22.
PubMed 25459097
Van Damme L, Corneli A, Ahmed K, Agot K, Lombaard J, Kapiga S, Malahleha M, Owino F, Manongi R, Onyango J, Temu L, Monedi MC, Mak'Oketch P, Makanda M, Reblin I, Makatu SE, Saylor L, Kiernan H, Kirkendale S, Wong C, Grant R, Kashuba A, Nanda K, Mandala J, Fransen K, Deese J, Crucitti T, Mastro TD, Taylor D; FEM-PrEP Study Group. Preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2012 Aug 2;367(5):411-22. doi: 10.1056/NEJMoa1202614. Epub 2012 Jul 11.
PubMed 22784040

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 3, Multi-center, Double-blind, Randomized, Placebo-controlled Effectiveness and Safety Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women
ClinicalTrials.gov ID: NCT00625404
Acronym / sponsor ID: 10015
Conditions: HIV Infections
Keywords: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), HIV, HIV Prevention, Oral PrEP, Truvada, women, Tenofovir
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,120 participants (actual)
Lead sponsor: FHI 360University, hospital or other
Study start: May 2009
Primary completion: Aug 2012 (actual)
Study completion: Jan 2013 (actual)
First posted: 28 Feb 2008 (estimated)
Results: Posted 16 Apr 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Truvada Arm	Experimental	Drug: TruvadaDaily single oral tablet of Truvada (TDF/FTC), a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
Placebo Arm	Placebo comparator	Other: PlaceboDaily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.

Who may qualify

Ages: 18 to 35 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (26 listed)

Willing and able (see criterion 2) to provide written informed consent to be screened for and to participate in the trial
Able to answer a percentage of informed consent screening (75%) and enrollment (100%) comprehension quiz questions correctly
Between 18-35 years old, inclusive
At higher risk of becoming HIV infected
Have a final negative result according to the site-specific screening HIV testing algorithm and a final negative result at enrollment according to the study HIV testing algorithm

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TruvadaAlso: TDF/FTC - emtricitabine and tenofovir disoproxil fumarateDaily single oral tablet of Truvada - a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).	Drug	Truvada Arm
PlaceboDaily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.	Other	Placebo Arm

Primary outcome

HIV Infection
Time frame: Cumulative HIV infection between enrollment and 52 weeks
HIV Seroconversion, with time to infection refined based on PCR results obtained from stored specimens.
Confirmed Grade 2 or Higher Serum Creatinine Toxicity
Time frame: cumulative toxicity through 52 weeks of product use and 4 weeks post product
Repeat specimens were collected to confirm chemistry toxicities. Grade 2 or higher serum creatinine toxicity was defined as ≥1.4 times the upper limit of normal
Frequency of Adverse Events (AEs) During and Within 4 Weeks After Study Product Administration
Time frame: 10-26 months per site
The total number of adverse events in the placebo and Truvada arms during and within 4 weeks after study product administration.
Confirmed Grade 3 or Higher Reduction in Phosphorus
Time frame: Through 52 weeks on product and 4 weeks post-product
Repeat specimens were collected to confirm chemistry toxicities. Grade 3 phosphorus reduction was defined as ≤2.4mg/dL
Confirmed Grade 3 or Higher ALT Elevation
Time frame: Through 52 weeks on product and 4 weeks post-product
Grade 3 or higher ALT elevation was defined as ≥ 2.6 times the upper limit of normal
Confirmed Grade 3 or Higher AST Elevation
Time frame: Through 52 weeks on product and 4 weeks post-product
Grade 3 or higher AST elevation was defined as ≥ 2.6 times the upper limit of normal

6 secondary outcomes

Plasma HIV RNA Level (HIV-1 Viral Load)
Time frame: up to 16 weeks
CD4+ T-cell Count
Time frame: Up to 16 weeks
FTC and/or Tenofovir Resistance
Time frame: up to 52 weeks
Pregnancy Complications
Time frame: up to 60 weeks
Pill Counts and Participant Report of Adherence to Once-daily Pill Taking
Time frame: Up to 52 weeks
Participant Report of Change in Number of Sexual Partners
Time frame: Up to 52 weeks

Results and safety

Results posted to the registry on 16 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Truvada Arm	1,062	855
Placebo Arm	1,058	885

Primary outcome: HIV Infection

Time frame: Cumulative HIV infection between enrollment and 52 weeks. Number. Unit: participants

Measure	Truvada Arm n = 1024	Placebo Arm n = 1032
Value	33 (3.25 to 6.63)	35 (3.47 to 6.93)

Truvada Arm vs Placebo Arm: Hazard Ratio (HR): 0.94 (95% CI 0.59 to 1.52)

Population analysed: All randomized participants who made at least one follow-up visit and were not HIV-positive at enrollment were included in the analysis population

Primary outcome: Confirmed Grade 2 or Higher Serum Creatinine Toxicity

Time frame: cumulative toxicity through 52 weeks of product use and 4 weeks post product. Number. Unit: participants

Measure	Truvada Arm n = 1021	Placebo Arm n = 1033
Value	4	2

Truvada Arm vs Placebo Arm: p = 0.45, Log Rank

Population analysed: The Safety Population consisted of all women who were randomized and who had at least one follow-up visit and did not return all of their product un-used. Only women assessed for a particular safety outcome were included in analysis of that outcome.

Primary outcome: Frequency of Adverse Events (AEs) During and Within 4 Weeks After Study Product Administration

Time frame: 10-26 months per site. Number. Unit: Number of adverse events

Measure	Truvada Arm n = 1025	Placebo Arm n = 1033
Value	2257	2384

Population analysed: The Safety Population, a subset of the ITT Population, excludes participants who never received study product, returned all product unused, or never returned for a follow-up visit. Analyses were performed by randomly assigned treatment group.

Primary outcome: Confirmed Grade 3 or Higher Reduction in Phosphorus

Time frame: Through 52 weeks on product and 4 weeks post-product. Number. Unit: participants

Measure	Truvada Arm n = 1021	Placebo Arm n = 1033
Value	45	40

Truvada Arm vs Placebo Arm: p = 0.59, Log Rank

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Truvada Arm	33 of 1,025 (3.2%)	761 of 1,025 (74.2%)	Not reported
Placebo Arm	23 of 1,033 (2.2%)	749 of 1,033 (72.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationLut Van Damme, M.D., Amy Corneli, Ph.D. and Douglas Taylor, Ph.D. New England Journal of Medicine 367: 411-422, 2012
Derived from this study: PubMed 25539648Mandala J, Nanda K, Wang M, De Baetselier I, Deese J, Lombaard J, Owino F, Malahleha M, Manongi R, Taylor D, Van Damme L. Liver and renal safety of tenofovir disoproxil fumarate in combination with emtricitabine among African women in a pre-exposure prophylaxis trial. BMC Pharmacol Toxicol. 2014 Dec 24;15:77. doi: 10.1186/2050-6511-15-77.
Derived from this study: PubMed 25503265Grant RM, Liegler T, Defechereux P, Kashuba AD, Taylor D, Abdel-Mohsen M, Deese J, Fransen K, De Baetselier I, Crucitti T, Bentley G, Agingu W, Ahmed K, Damme LV. Drug resistance and plasma viral RNA level after ineffective use of oral pre-exposure prophylaxis in women. AIDS. 2015 Jan 28;29(3):331-7. doi: 10.1097/QAD.0000000000000556.
Derived from this study: PubMed 25459097Todd CS, Deese J, Wang M, Hubacher D, Steiner MJ, Otunga S, Van Damme L; FEM-PrEP Study Group. Sino-implant (II)(R) continuation and effect of concomitant tenofovir disoproxil fumarate-emtricitabine use on plasma levonorgestrel concentrations among women in Bondo, Kenya. Contraception. 2015 Mar;91(3):248-52. doi: 10.1016/j.contraception.2014.10.008. Epub 2014 Oct 22.
Derived from this study: PubMed 22784040Van Damme L, Corneli A, Ahmed K, Agot K, Lombaard J, Kapiga S, Malahleha M, Owino F, Manongi R, Onyango J, Temu L, Monedi MC, Mak'Oketch P, Makanda M, Reblin I, Makatu SE, Saylor L, Kiernan H, Kirkendale S, Wong C, Grant R, Kashuba A, Nanda K, Mandala J, Fransen K, Deese J, Crucitti T, Mastro TD, Taylor D; FEM-PrEP Study Group. Preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2012 Aug 2;367(5):411-22. doi: 10.1056/NEJMoa1202614. Epub 2012 Jul 11.
Genetics Home Reference for complement factor I deficiencyLink provided by the sponsor.
MedlinePlus: AIDSLink provided by the sponsor.
MedlinePlus: HepatitisLink provided by the sponsor.
Drug Information: n-Octadecanoic acidLink provided by the sponsor.
Drug Information: Calcium stearateLink provided by the sponsor.
Drug Information : Aluminum monostearateLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lut Van Damme, MD, MS, PhD principal investigator

FHI 360

Amy Corneli, PhD, MPH principal investigator

FHI 360

Jennifer Deese, MPH study director

FHI 360

4 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Truvada in people with HIV Infections, run by FHI 360 at 4 sites in 3 countries.

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 26 inclusion and 0 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 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in South Africa, Kenya, Tanzania. 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

HIV Infection (time frame: Cumulative HIV infection between enrollment and 52 weeks). The study lists 6 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 NCT00625404, which also lists 5 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 26 Jul 2018.