HIV InfectionPhase 3IPERGAYNCT01473472
On Demand Antiretroviral Pre-exposure Prophylaxis for HIV Infection in Men Who Have Sex With Men
A Phase 3 study testing Truvada in people with HIV Infection, run by ANRS, Emerging Infectious Diseases at 7 sites in 2 countries.
Trial summary
This phase III, multi-centre, comparative, double-blind, randomized trial on 2 parallel groups is designed to evaluate a strategy for the prevention of HIV infection including "on demand" antiretroviral pre-exposure with Truvada versus placebo, associated with overall prevention (counselling, condoms, sexually… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infection
- What is being tested?
- Truvada
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Jan 2012to 15 Dec 2016
- Phase
- Phase 3
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Male (or transgender) having sex with men
- Not infected with HIV-1 or HIV-2
- Elevated risk of HIV contamination : anal sexual relations with at least 2 different sexual partners within the past 6 months without the systematic use of a condom
- Satisfactory kidney function with a clearance of more than 60 mL/min (Cockcroft formula)
- Alanine aminotransferase (ALT) < 2.5 Upper Limit of Normal (ULN),
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- Neutrophil granulocytes ≥ 1 000/mm3, haemoglobin ≥ 10 g/dL, platelets ≥ 150 000/mm3
- Negative HBs antigen and negative hepatitis C virus (HCV) serology (or negative HCV PCR if positive serology)
- Agrees to be contacted personally, if possible by telephone, short message system (SMS) or e-mail
- Agrees to the constraints imposed by the trial (visits every 2 months)
- Subjects enrolled in or a beneficiary of a Social Security program (State Medical Aid or Aide médicale de l'Etat (AME) is not a Social Security program).
- Signature of the informed consent form.
Who cannot join
- Subject in a stable and exclusive relationship with a person
- Systematic use of a condom during sexual relations
- Expected to go abroad for more than 3 consecutive months or move expected to a city where the study is not being conducted.
- Presence of significant glycosuria or proteinuria > 1+ in the urine dipstick, in the absence of infection.
- Presence of significant haematuria or leukocyturia > 2+ in the urine dipstick, in the absence of infection.
- History of chronic kidney disease, osteoporosis, osteopaenia
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- History of pathological bone fracture not related to trauma
- Treatment with Interferon, Interleukin, or antiretrovirals
- Treatment that could inhibit or compete with the tubular secretion of antiretrovirals
- Treatment undergoing investigation
- Intravenous toxicomania
- Subject who is currently receiving or going to receive a potentially nephrotoxic treatment (long-term anti-inflammatory)
- Gastro-intestinal disease (or chronic nausea or vomiting) disrupting the absorption of treatments
- Positive HBs antigen
- Positive HCV serology with positive HCV PCR
- Life-threatening disease (lymphoma) or other serious disease (cardiovascular, renal, pulmonary, unstable diabetes) that could require treatment that could disrupt adherence to the treatment
- Subject potentially non-compliant.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
France6 sites
Hôpital de La Croix Rousse
Lyon
CHU Hôtel Dieu
Nantes, 44093
Hôpital de l'Archet
Nice, 06202
Hôpital Saint-Louis
Paris, 75475
Hôpital Tenon
Paris, 75
Hôpital Gustave Dron
Tourcoing, 59208
About this study
This phase III, multi-centre, comparative, double-blind, randomized trial on 2 parallel groups is designed to evaluate a strategy for the prevention of HIV infection including "on demand" antiretroviral pre-exposure with Truvada versus placebo, associated with overall prevention (counselling, condoms, sexually transmitted diseases (STD) screening, hepatitis B virus (HBV) and hepatitis A virus (HAV) vaccinations and post-exposure treatment of HIV infection) in men who have sex with men (MSM), exposed to the risk of HIV infection. Indeed recent studies have reported a higher incidence of new HIV infection in MSM as compared to the general population, new approaches to the prevention of HIV infection are, therefore, necessary in order to consider the limits of current strategies.
Read the detailed description
The trial has been taken place in two phases in order to ensure the general feasibility of the study:
- a first enrollment phase for at least 300 participants to ensure the possibility for recruitment in France and Canada and to validate the tools put into place as part of the trial to enroll and follow participants
- a second phase of 1600 additional participants. This extension phase started on July 2014.
The recruitment has been suspended following the recommendations of Data Safety and Monitoring Board (DSMB): the placebo arm has been stopped and Truvada was available for all the participants of the trial since November 2014. The initial protocol was amended and 361 participants were enrolled in the open-label phase. Sub-studies were proposed to the participants:
- Sub-study on the outcome of participants receiving sofosbuvir/ledipasvir treatment for recent HCV infection (protocol amendment on April 2015)
- Randomized sub-study to evaluate the efficacy of doxycycline post-exposure prophylaxis on sexually transmitted infections (protocol amendment on July 2015)
- Sub-study to evaluate Truvada adherence with Medication Event Monitoring System (MEMS) (protocol amendment on December 2015)
- Sub-study on drugs use and the impact on sexual behavior and Truvada adherence (protocol amendment on December 2015).
- Conditions
- HIV Infection
- Being tested
- Truvada, Placebo
- Keywords
- Prophylaxis, HIV infection, tenofovir, emtricitabine, men who have sex with men
- Medical subject headings
- HIV Infections, Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TruvadaDrug
Also called tenofovir disoproxil and emtricitabine
2 tablets of truvada within 24 hours before first sexual relations, then 1 tablet of Truvada during the period of sexual activity including the last sexual intercourse, finally, a last dose of 1 tablet of Truvada approximately 24 hours later
PlaceboDrug
2 tablets of placebo within 24 hours before first sexual relations, then 1 tablet of placebo every 24 hours during the period of sexual activity including the last sexual intercourse, finally, a last dose of 1 tablet of placebo approximatively 24 hours later
| Study group | Role | What they receive |
|---|---|---|
| Truvada | Active comparator | associated with an overall offer of prevention (counselling, STD screening, condoms, HAV and HBV vaccinations, treatment post-exposure to the HIV infection) Receives: Drug: Truvada |
| Placebo of Truvada | Placebo comparator | associated with an overall offer of prevention (counselling, STD screening, condoms, HAV and HBV vaccinations, treatment post-exposure to the HIV infection) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contamination with HIV-1 or -2
The primary endpoint criteria is contamination with HIV-1 or -2, defined by the first diagnostic proof of infection: positive HIV serum test (using combined latest-generation tests HIV-1 + 2) or a positive test for HIV-1-RNA Polymerase Chain Reaction (PCR) in the plasma.
Measured: From randomization to the end of the trial. The trial end date will be set by the scientific committee when the necessary number of primary endpoints has been reached without exceeding 5 years of follow-up.
Secondary outcomes (8)
Evolution of sexual behavior and potential at-risk behavior
Self-questionnaires
Measured: Every 2 months without exceeding 5 years of follow-up.
Incidence of clinical and biological adverse events
Measured: From randomization to the end of the trial, without exceeding 5 years of follow-up.
Treatment adherence
Self-questionnaires, pill count. Drugs levels in plasma and hair (every 4 months).
Measured: Every 2 months without exceeding 5 years of follow-up.
Incidence of hepatitis B
Measured: From randomization to the end of the trial, without exceeding 5 years of follow-up
Incidence of other sexually transmitted diseases
Measured: From randomization to the end of the trial, without exceeding 5 years of follow-up
Frequency of HIV resistance to antiretrovirals in HIV infected subjects
Genotype
Measured: At a visit as soon as the HIV infection is diagnosed
Emtricitabine and tenofovir concentrations in plasma, saliva and rectal samples.
Ancillary study proposed between week-4 and the randomization - 12 volunteers. Blood and saliva samples at all time points and 2 sessions with rectal biopsies at two times for each volunteer (one before the drug is taken and one at one time after taking the 2 tablets)
Measured: 0, 30 min, 1, 2, 4, 8 and 24 hours post-dose (2 tablets of Truvada)
Costs evaluation
Modelling to estimate an increase of years of life expectancy and of quality adjusted life year (QALY).
Cost per avoided HIV contamination
Measured: From randomization to the end of the trial, without exceeding 5 years of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startJan 2012
- Primary completion30 Jun 2016
- Study completion15 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- 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
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jean-Michel MOLINA, Professor, Principal investigator, Hôpital Saint-Louis Paris FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473472
- Sponsor's protocol ID
- 2011-002645-35
- Other IDs
- IPERGAY
- Acronym
- IPERGAY
- Status last verified
- May 2017
- First submitted
- 8 Nov 2011
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Chawki S, Leturque N, Minier M, Gabassi A, Foubert V, Charreau I, Cua E, Pialoux G, Meyer L, Molina JM, Delaugerre C. Prevalence and Risk Factors of Cytomegalovirus Among Men Having Sex With Men Enrolled in a Pre-Exposure Prophylaxis Study. Open Forum Infect Dis. 2024 Jul 18;11(8):ofae400. doi: 10.1093/ofid/ofae400. eCollection 2024 Aug.
PubMed 39100527Antoni G, Tremblay C, Delaugerre C, Charreau I, Cua E, Rojas Castro D, Raffi F, Chas J, Huleux T, Spire B, Capitant C, Cotte L, Meyer L, Molina JM; ANRS IPERGAY study group. On-demand pre-exposure prophylaxis with tenofovir disoproxil fumarate plus emtricitabine among men who have sex with men with less frequent sexual intercourse: a post-hoc analysis of the ANRS IPERGAY trial. Lancet HIV. 2020 Feb;7(2):e113-e120. doi: 10.1016/S2352-3018(19)30341-8. Epub 2019 Nov 26.
PubMed 31784343Molina JM, Charreau I, Chidiac C, Pialoux G, Cua E, Delaugerre C, Capitant C, Rojas-Castro D, Fonsart J, Bercot B, Bebear C, Cotte L, Robineau O, Raffi F, Charbonneau P, Aslan A, Chas J, Niedbalski L, Spire B, Sagaon-Teyssier L, Carette D, Mestre SL, Dore V, Meyer L; ANRS IPERGAY Study Group. Post-exposure prophylaxis with doxycycline to prevent sexually transmitted infections in men who have sex with men: an open-label randomised substudy of the ANRS IPERGAY trial. Lancet Infect Dis. 2018 Mar;18(3):308-317. doi: 10.1016/S1473-3099(17)30725-9. Epub 2017 Dec 8.
PubMed 29229440Molina JM, Charreau I, Spire B, Cotte L, Chas J, Capitant C, Tremblay C, Rojas-Castro D, Cua E, Pasquet A, Bernaud C, Pintado C, Delaugerre C, Sagaon-Teyssier L, Mestre SL, Chidiac C, Pialoux G, Ponscarme D, Fonsart J, Thompson D, Wainberg MA, Dore V, Meyer L; ANRS IPERGAY Study Group. Efficacy, safety, and effect on sexual behaviour of on-demand pre-exposure prophylaxis for HIV in men who have sex with men: an observational cohort study. Lancet HIV. 2017 Sep;4(9):e402-e410. doi: 10.1016/S2352-3018(17)30089-9. Epub 2017 Jul 23.
PubMed 28747274Molina JM, Capitant C, Spire B, Pialoux G, Cotte L, Charreau I, Tremblay C, Le Gall JM, Cua E, Pasquet A, Raffi F, Pintado C, Chidiac C, Chas J, Charbonneau P, Delaugerre C, Suzan-Monti M, Loze B, Fonsart J, Peytavin G, Cheret A, Timsit J, Girard G, Lorente N, Preau M, Rooney JF, Wainberg MA, Thompson D, Rozenbaum W, Dore V, Marchand L, Simon MC, Etien N, Aboulker JP, Meyer L, Delfraissy JF; ANRS IPERGAY Study Group. On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection. N Engl J Med. 2015 Dec 3;373(23):2237-46. doi: 10.1056/NEJMoa1506273. Epub 2015 Dec 1.
PubMed 26624850
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On Demand Antiretroviral Pre-exposure Prophylaxis for HIV Infection in Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT01473472
- Acronym / sponsor ID
- IPERGAY / 2011-002645-35
- Conditions
- HIV Infection
- Keywords
- Prophylaxis, HIV infection, tenofovir, emtricitabine, men who have sex with men
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- Jan 2012
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 15 Dec 2016 (actual)
- First posted
- 17 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase III, multi-centre, comparative, double-blind, randomized trial on 2 parallel groups is designed to evaluate a strategy for the prevention of HIV infection including "on demand" antiretroviral pre-exposure with Truvada versus placebo, associated with overall prevention (counselling, condoms, sexually transmitted diseases (STD) screening, hepatitis B virus (HBV) and hepatitis A virus (HAV) vaccinations and post-exposure treatment of HIV infection) in men who have sex with men (MSM), exposed to the risk of HIV infection. Indeed recent studies have reported a higher incidence of new HIV infection in MSM as compared to the general population, new approaches to the prevention of HIV infection are, therefore, necessary in order to consider the limits of current strategies.
Detailed description
The trial has been taken place in two phases in order to ensure the general feasibility of the study:
- a first enrollment phase for at least 300 participants to ensure the possibility for recruitment in France and Canada and to validate the tools put into place as part of the trial to enroll and follow participants
- a second phase of 1600 additional participants. This extension phase started on July 2014.
The recruitment has been suspended following the recommendations of Data Safety and Monitoring Board (DSMB): the placebo arm has been stopped and Truvada was available for all the participants of the trial since November 2014. The initial protocol was amended and 361 participants were enrolled in the open-label phase. Sub-studies were proposed to the participants:
- Sub-study on the outcome of participants receiving sofosbuvir/ledipasvir treatment for recent HCV infection (protocol amendment on April 2015)
- Randomized sub-study to evaluate the efficacy of doxycycline post-exposure prophylaxis on sexually transmitted infections (protocol amendment on July 2015)
- Sub-study to evaluate Truvada adherence with Medication Event Monitoring System (MEMS) (protocol amendment on December 2015)
- Sub-study on drugs use and the impact on sexual behavior and Truvada adherence (protocol amendment on December 2015).
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 | Active comparator | Drug: Truvadaassociated with an overall offer of prevention (counselling, STD screening, condoms, HAV and HBV vaccinations, treatment post-exposure to the HIV infection) |
| Placebo of Truvada | Placebo comparator | Drug: Placeboassociated with an overall offer of prevention (counselling, STD screening, condoms, HAV and HBV vaccinations, treatment post-exposure to the HIV infection) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years old
- Male (or transgender) having sex with men
- Not infected with HIV-1 or HIV-2
- Elevated risk of HIV contamination : anal sexual relations with at least 2 different sexual partners within the past 6 months without the systematic use of a condom
- Satisfactory kidney function with a clearance of more than 60 mL/min (Cockcroft formula)
Key exclusion criteria (17 listed)
- Subject in a stable and exclusive relationship with a person
- Systematic use of a condom during sexual relations
- Expected to go abroad for more than 3 consecutive months or move expected to a city where the study is not being conducted.
- Presence of significant glycosuria or proteinuria > 1+ in the urine dipstick, in the absence of infection.
- Presence of significant haematuria or leukocyturia > 2+ in the urine dipstick, in the absence of infection.
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: tenofovir disoproxil and emtricitabine2 tablets of truvada within 24 hours before first sexual relations, then 1 tablet of Truvada during the period of sexual activity including the last sexual intercourse, finally, a last dose of 1 tablet of Truvada approximately 24 hours later | Drug | Truvada |
| Placebo2 tablets of placebo within 24 hours before first sexual relations, then 1 tablet of placebo every 24 hours during the period of sexual activity including the last sexual intercourse, finally, a last dose of 1 tablet of placebo approximatively 24 hours later | Drug | Placebo of Truvada |
Primary outcome
Contamination with HIV-1 or -2
Time frame: From randomization to the end of the trial. The trial end date will be set by the scientific committee when the necessary number of primary endpoints has been reached without exceeding 5 years of follow-up.
The primary endpoint criteria is contamination with HIV-1 or -2, defined by the first diagnostic proof of infection: positive HIV serum test (using combined latest-generation tests HIV-1 + 2) or a positive test for HIV-1-RNA Polymerase Chain Reaction (PCR) in the plasma.
8 secondary outcomes
Evolution of sexual behavior and potential at-risk behavior
Time frame: Every 2 months without exceeding 5 years of follow-up.
Incidence of clinical and biological adverse events
Time frame: From randomization to the end of the trial, without exceeding 5 years of follow-up.
Treatment adherence
Time frame: Every 2 months without exceeding 5 years of follow-up.
Incidence of hepatitis B
Time frame: From randomization to the end of the trial, without exceeding 5 years of follow-up
Incidence of other sexually transmitted diseases
Time frame: From randomization to the end of the trial, without exceeding 5 years of follow-up
Frequency of HIV resistance to antiretrovirals in HIV infected subjects
Time frame: At a visit as soon as the HIV infection is diagnosed
Emtricitabine and tenofovir concentrations in plasma, saliva and rectal samples.
Time frame: 0, 30 min, 1, 2, 4, 8 and 24 hours post-dose (2 tablets of Truvada)
Costs evaluation
Time frame: From randomization to the end of the trial, without exceeding 5 years of follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Derived from this study: PubMed 39100527Chawki S, Leturque N, Minier M, Gabassi A, Foubert V, Charreau I, Cua E, Pialoux G, Meyer L, Molina JM, Delaugerre C. Prevalence and Risk Factors of Cytomegalovirus Among Men Having Sex With Men Enrolled in a Pre-Exposure Prophylaxis Study. Open Forum Infect Dis. 2024 Jul 18;11(8):ofae400. doi: 10.1093/ofid/ofae400. eCollection 2024 Aug.
- Derived from this study: PubMed 31784343Antoni G, Tremblay C, Delaugerre C, Charreau I, Cua E, Rojas Castro D, Raffi F, Chas J, Huleux T, Spire B, Capitant C, Cotte L, Meyer L, Molina JM; ANRS IPERGAY study group. On-demand pre-exposure prophylaxis with tenofovir disoproxil fumarate plus emtricitabine among men who have sex with men with less frequent sexual intercourse: a post-hoc analysis of the ANRS IPERGAY trial. Lancet HIV. 2020 Feb;7(2):e113-e120. doi: 10.1016/S2352-3018(19)30341-8. Epub 2019 Nov 26.
- Derived from this study: PubMed 29229440Molina JM, Charreau I, Chidiac C, Pialoux G, Cua E, Delaugerre C, Capitant C, Rojas-Castro D, Fonsart J, Bercot B, Bebear C, Cotte L, Robineau O, Raffi F, Charbonneau P, Aslan A, Chas J, Niedbalski L, Spire B, Sagaon-Teyssier L, Carette D, Mestre SL, Dore V, Meyer L; ANRS IPERGAY Study Group. Post-exposure prophylaxis with doxycycline to prevent sexually transmitted infections in men who have sex with men: an open-label randomised substudy of the ANRS IPERGAY trial. Lancet Infect Dis. 2018 Mar;18(3):308-317. doi: 10.1016/S1473-3099(17)30725-9. Epub 2017 Dec 8.
- Derived from this study: PubMed 28747274Molina JM, Charreau I, Spire B, Cotte L, Chas J, Capitant C, Tremblay C, Rojas-Castro D, Cua E, Pasquet A, Bernaud C, Pintado C, Delaugerre C, Sagaon-Teyssier L, Mestre SL, Chidiac C, Pialoux G, Ponscarme D, Fonsart J, Thompson D, Wainberg MA, Dore V, Meyer L; ANRS IPERGAY Study Group. Efficacy, safety, and effect on sexual behaviour of on-demand pre-exposure prophylaxis for HIV in men who have sex with men: an observational cohort study. Lancet HIV. 2017 Sep;4(9):e402-e410. doi: 10.1016/S2352-3018(17)30089-9. Epub 2017 Jul 23.
- Derived from this study: PubMed 26624850Molina JM, Capitant C, Spire B, Pialoux G, Cotte L, Charreau I, Tremblay C, Le Gall JM, Cua E, Pasquet A, Raffi F, Pintado C, Chidiac C, Chas J, Charbonneau P, Delaugerre C, Suzan-Monti M, Loze B, Fonsart J, Peytavin G, Cheret A, Timsit J, Girard G, Lorente N, Preau M, Rooney JF, Wainberg MA, Thompson D, Rozenbaum W, Dore V, Marchand L, Simon MC, Etien N, Aboulker JP, Meyer L, Delfraissy JF; ANRS IPERGAY Study Group. On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection. N Engl J Med. 2015 Dec 3;373(23):2237-46. doi: 10.1056/NEJMoa1506273. Epub 2015 Dec 1.
- sponsor of the studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jean-Michel MOLINA, Professor principal investigator
Hôpital Saint-Louis Paris FRANCE
7 sites in 2 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 Infection, run by ANRS, Emerging Infectious Diseases at 7 sites in 2 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 12 inclusion and 17 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 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France, Canada. 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?
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?
Contamination with HIV-1 or -2 (time frame: From randomization to the end of the trial. The trial end date will be set by the scientific committee when the necessary number of primary endpoints has been reached without exceeding 5 years of follow-up.). 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 NCT01473472, 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 11 May 2017.