HIV-1 InfectionPhase 2NCT02397694

Safety and Efficacy of Bictegravir + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

A Phase 2 study testing BIC, F/TAF and DTG in people with HIV-1 Infection, run by Gilead Sciences at 21 sites in United States.

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 efficacy, safety and tolerability of bictegravir (BIC) + emtricitabine/tenofovir alafenamide (F/TAF) fixed dose combination (FDC) versus dolutegravir (DTG) + F/TAF in HIV-1 Infected, antiretroviral treatment-naive adults. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV-1 Infection
What is being tested?: BIC, F/TAF and DTG
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 98 participants
Where: 21 sitesUnited States
Study dates: 23 Mar 2015to 27 Feb 2019
Phase: Phase 2
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Antiretroviral naive (≤ 10 days of prior therapy with any antiretroviral agent)
Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
Screening genotype report provided by Gilead Sciences must show sensitivity to tenofovir (TFV) and emtricitabine (FTC)
Adequate renal function as measured by estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft-Gault formula
CD4+ cell count ≥ 200 cells/µL at screening

Who cannot join

A new AIDS-defining condition diagnosed within the 30 days prior to screening as defined in the study protocol
Prior use of antiretrovirals in the setting of pre-exposure prophylaxis (PrEP) or post exposure prophylaxis (PEP)
Chronic hepatitis B virus (HBV) infection
Hepatitis C infection (Individuals who are hepatitis C virus (HCV) Ab positive, but have a documented negative HCV RNA, are eligible)
Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

United States21 sites

Study site
Annandale, Virginia, 22003
Study site
Atlanta, Georgia, 30312
Study site
Austin, Texas, 78705
Study site
Berkley, Michigan, 48072
Study site
Boston, Massachusetts, 02115
Study site
Dallas, Texas, 75208
Study site
Decatur, Georgia, 30033
Study site
Fort Lauderdale, Florida, 33316
Study site
Houston, Texas, 77004
Study site
Houston, Texas, 77098
Study site
Longview, Texas, 75605
Study site
Los Angeles, California, 90036
Study site
Los Angeles, California, 90069
Study site
Newark, New Jersey, 07102
Study site
Orlando, Florida, 32803
Study site
Phoenix, Arizona, 85012
Study site
Sacramento, California, 95817
Study site
Seattle, Washington, 98104
Study site
Washington D.C., District of Columbia, 20009
Study site
Washington D.C., District of Columbia, 20036
Study site
West Palm Beach, Florida, 33401

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of GS-9883 + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

Conditions: HIV-1 Infection
Being tested: BIC, F/TAF, DTG, BIC Placebo, DTG Placebo
Keywords: Adult, HIV, naive

What participants receive

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

BICDrug
Also called GS-9883
75 mg tablet administered orally once daily
F/TAFDrug
200/25 mg FDC tablet administered orally once daily
DTGDrug
Also called Tivicay®
50 mg tablet administered orally once daily
BIC PlaceboDrug
Tablet administered orally once daily
DTG PlaceboDrug
Tablet administered orally once daily
B/F/TAFDrug
50/200/25 mg FDC tablet administered orally once daily

Study groups in NCT02397694
Study group	Role	What they receive
BIC + F/TAF	Experimental	Participants will receive BIC + F/TAF FDC + DTG placebo for 48 weeks. * Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF. Receives: Drug: BIC; Drug: F/TAF; Drug: DTG Placebo; Drug: B/F/TAF
DTG + F/TAF	Active comparator	Participants will receive DTG + F/TAF FDC + BIC placebo for 48 weeks. * Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive B/F/TAF until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF. Receives: Drug: F/TAF; Drug: DTG; Drug: BIC Placebo; Drug: B/F/TAF
Open Label Extension Phase	Experimental	After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF. Receives: Drug: B/F/TAF

What is being measured

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

Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm.
The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Measured: Week 24

Secondary outcomes (15)

Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 12
The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 12 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Measured: Week 12
Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 48
The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Measured: Week 48
The Change From Baseline in log10 HIV-1 RNA at Week 12
Measured: Baseline; Week 12
The Change From Baseline in log10 HIV-1 RNA at Week 24
Measured: Baseline; Week 24
The Change From Baseline in log10 HIV-1 RNA at Week 48
Measured: Baseline; Week 48
The Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 12
Measured: Baseline; Week 12
The Change From Baseline in CD4+ Cell Count at Week 24
Measured: Baseline; Week 24
The Change From Baseline in CD4+ Cell Count at Week 48
Measured: Baseline; Week 48
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) During Double-Blinded Randomized Phase
Measured: First dose date up to last dose (maximum duration: 58 Weeks) plus 30 days (During Double-Blinded Randomized Phase)
Percentage of Participants With Treatment Emergent Laboratory Abnormalities During Double-Blind Randomized Phase
Measured: First dose date up to last dose (maximum duration: 58 Weeks) plus 30 days (During Double-Blinded Randomized Phase)
PK Parameter: Cmax for Bictegravir (BIC), Emtricitabine (FTC), Tenofovir Alafenamide (TAF) and Tenofavir (TFV) at Steady-State
Cmax is the maximum observed plasma concentration of the drug.
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8
PK Parameter: Tmax for BIC, FTC, TAF, and TFV at Steady-State
Tmax was defined as the time to Cmax.
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8
PK Parameter:Ctau for BIC, FTC and TFV
Ctau was defined as the observed drug concentration at the end of the dosing interval.
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8
PK Parameter: AUCtau for BIC, FTC, TAF, and TFV
AUCtau is defined as the area under the concentration-time curve of the drug over time.
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8
PK Parameter: t1/2 of BIC, FTC, TAF, and TFV
t1/2 was defined as the terminal elimination half-life of the drug
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8

Timeline

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

23 Mar 201527 Feb 2019

First posted25 Mar 2015 (estimated)
Study start23 Mar 2015
Primary completion30 Nov 2015
Study completion27 Feb 2019

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 (2)Papers the sponsor has linked to this study.
Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
More trials run by Gilead SciencesThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 98 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02397694
Sponsor's protocol ID: GS-US-141-1475
Status last verified: Mar 2020
First submitted: 20 Mar 2015
Last updated: 7 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Sax PE, DeJesus E, Crofoot G, Ward D, Benson P, Dretler R, Mills A, Brinson C, Peloquin J, Wei X, White K, Cheng A, Martin H, Quirk E. Bictegravir versus dolutegravir, each with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection: a randomised, double-blind, phase 2 trial. Lancet HIV. 2017 Apr;4(4):e154-e160. doi: 10.1016/S2352-3018(17)30016-4. Epub 2017 Feb 15.
PubMed 28219610
Sax PE, DeJesus E, Crofoot G, Ward D, Benson P, Dretler R, Mills A, Brinson C, Wei X, Collins SE, Cheng A. Coformulated bictegravir, emtricitabine, tenofovir alafenamide after initial treatment with bictegravir or dolutegravir and emtricitabine/tenofovir alafenamide. AIDS. 2018 Jul 31;32(12):1723-1725. doi: 10.1097/QAD.0000000000001894.
PubMed 29794828

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?

See locations

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HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
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Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
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All HIV-1 Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of GS-9883 + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
ClinicalTrials.gov ID: NCT02397694
Acronym / sponsor ID: GS-US-141-1475
Conditions: HIV-1 Infection
Keywords: Adult, HIV, naive
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 98 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: 23 Mar 2015 (actual)
Primary completion: 30 Nov 2015 (actual)
Study completion: 27 Feb 2019 (actual)
First posted: 25 Mar 2015 (estimated)
Results: Posted 27 Mar 2018

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
BIC + F/TAF	Experimental	Drug: BIC, Drug: F/TAF, Drug: DTG Placebo, Drug: B/F/TAFParticipants will receive BIC + F/TAF FDC + DTG placebo for 48 weeks. * Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF.
DTG + F/TAF	Active comparator	Drug: F/TAF, Drug: DTG, Drug: BIC Placebo, Drug: B/F/TAFParticipants will receive DTG + F/TAF FDC + BIC placebo for 48 weeks. * Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive B/F/TAF until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF.
Open Label Extension Phase	Experimental	Drug: B/F/TAFAfter Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Antiretroviral naive (≤ 10 days of prior therapy with any antiretroviral agent)
Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
Screening genotype report provided by Gilead Sciences must show sensitivity to tenofovir (TFV) and emtricitabine (FTC)
Adequate renal function as measured by estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft-Gault formula
CD4+ cell count ≥ 200 cells/µL at screening

Key exclusion criteria (7 listed)

A new AIDS-defining condition diagnosed within the 30 days prior to screening as defined in the study protocol
Prior use of antiretrovirals in the setting of pre-exposure prophylaxis (PrEP) or post exposure prophylaxis (PEP)
Chronic hepatitis B virus (HBV) infection
Hepatitis C infection (Individuals who are hepatitis C virus (HCV) Ab positive, but have a documented negative HCV RNA, are eligible)
Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline

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
BICAlso: GS-988375 mg tablet administered orally once daily	Drug	BIC + F/TAF
F/TAF200/25 mg FDC tablet administered orally once daily	Drug	BIC + F/TAF, DTG + F/TAF
DTGAlso: Tivicay®50 mg tablet administered orally once daily	Drug	DTG + F/TAF
BIC PlaceboTablet administered orally once daily	Drug	DTG + F/TAF
DTG PlaceboTablet administered orally once daily	Drug	BIC + F/TAF
B/F/TAF50/200/25 mg FDC tablet administered orally once daily	Drug	BIC + F/TAF, DTG + F/TAF, Open Label Extension Phase

Primary outcome

Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm.
Time frame: Week 24
The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

15 secondary outcomes

Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 12
Time frame: Week 12
Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 48
Time frame: Week 48
The Change From Baseline in log10 HIV-1 RNA at Week 12
Time frame: Baseline; Week 12
The Change From Baseline in log10 HIV-1 RNA at Week 24
Time frame: Baseline; Week 24
The Change From Baseline in log10 HIV-1 RNA at Week 48
Time frame: Baseline; Week 48
The Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 12
Time frame: Baseline; Week 12
The Change From Baseline in CD4+ Cell Count at Week 24
Time frame: Baseline; Week 24
The Change From Baseline in CD4+ Cell Count at Week 48
Time frame: Baseline; Week 48
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) During Double-Blinded Randomized Phase
Time frame: First dose date up to last dose (maximum duration: 58 Weeks) plus 30 days (During Double-Blinded Randomized Phase)
Percentage of Participants With Treatment Emergent Laboratory Abnormalities During Double-Blind Randomized Phase
Time frame: First dose date up to last dose (maximum duration: 58 Weeks) plus 30 days (During Double-Blinded Randomized Phase)
PK Parameter: Cmax for Bictegravir (BIC), Emtricitabine (FTC), Tenofovir Alafenamide (TAF) and Tenofavir (TFV) at Steady-State
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8
PK Parameter: Tmax for BIC, FTC, TAF, and TFV at Steady-State
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8
PK Parameter:Ctau for BIC, FTC and TFV
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8
PK Parameter: AUCtau for BIC, FTC, TAF, and TFV
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8
PK Parameter: t1/2 of BIC, FTC, TAF, and TFV
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8

Results and safety

Results posted to the registry on 27 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BIC + F/TAF	65	62
DTG + F/TAF	33	30

Primary outcome: Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm.

Time frame: Week 24. Number. Unit: percentage of participants

Measure	BIC + F/TAF n = 65	DTG + F/TAF n = 33
Value	96.9	93.9

BIC + F/TAF vs DTG + F/TAF: Difference in percentages: 2.9 (95% CI -8.5 to 14.2), p = 0.5, Cochran-Mantel-Haenszel

Population analysed: Full Analysis Set included all participants who were randomized into the double-blinded phase of study and received at least 1 dose of study drug during the double-blinded phase.

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BIC + F/TAF (Double-Blind Randomized)	4 of 65 (6.2%)	44 of 65 (67.7%)	0 of 65
DTG + F/TAF (Double Blind Randomized):	0 of 33 (0%)	18 of 33 (54.5%)	0 of 33
BIC + F/TAF to B/F/TAF (Open-Label Phase)	3 of 62 (4.8%)	42 of 62 (67.7%)	0 of 62
DTG + F/TAF to B/F/TAF (Open-Label Phase)	5 of 30 (16.7%)	23 of 30 (76.7%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28219610Sax PE, DeJesus E, Crofoot G, Ward D, Benson P, Dretler R, Mills A, Brinson C, Peloquin J, Wei X, White K, Cheng A, Martin H, Quirk E. Bictegravir versus dolutegravir, each with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection: a randomised, double-blind, phase 2 trial. Lancet HIV. 2017 Apr;4(4):e154-e160. doi: 10.1016/S2352-3018(17)30016-4. Epub 2017 Feb 15.
Results publication: PubMed 29794828Sax PE, DeJesus E, Crofoot G, Ward D, Benson P, Dretler R, Mills A, Brinson C, Wei X, Collins SE, Cheng A. Coformulated bictegravir, emtricitabine, tenofovir alafenamide after initial treatment with bictegravir or dolutegravir and emtricitabine/tenofovir alafenamide. AIDS. 2018 Jul 31;32(12):1723-1725. doi: 10.1097/QAD.0000000000001894.
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.

Gilead Study Director study director

Gilead Sciences

21 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BIC, F/TAF and DTG in people with HIV-1 Infection, run by Gilead Sciences at 21 sites in United States.

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 5 inclusion and 7 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 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. 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. 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 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?

Yes. Results are posted in the registry (first posted 27 Mar 2018). 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?

Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm. (time frame: Week 24). 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 NCT02397694, 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 7 Apr 2020.