HIV-1-infectionPhase 4ReSTARTNCT04388904
Rapid Reinitiation of a Single Tablet Antiretroviral Therapy Using Symtuza® in HIV-1 Infected Treatment-Experienced Patients Off Therapy. (ReSTART)
A Phase 4 study testing Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (FDC) in people with HIV-1-infection, run by The Crofoot Research Center, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate the effectiveness of Symtuza® in a rapid reinitiation model of care in patients with HIV-1 infection and who are treatment-experienced but have been off of antiretroviral therapy (ART) for 12 or more weeks. 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?
- Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (FDC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 5 Apr 2024
- Phase
- Phase 4
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age at screening/baseline visit.
- Antiretroviral treatment-experienced and have not received any anti-HIV treatment within 12 weeks prior to screening.
- Contraceptive use by men or women should be consistent with the local regulations regarding the use of contraceptive methods for subject participating in clinical studies.
- Men must agree not to donate sperm during the study until 90 days after receiving the last dose of study drug (or longer, if dictated by local regulations).
- Must be able to swallow whole tablets or swallow tablets cut into halves.
Who cannot join
- Known active cryptococcal infection, active toxoplasmic encephalitis, Mycobacterium tuberculosis infection, or another AIDS-defining condition that in the judgment of the investigator would increase the risk of morbidity or mortality.
- Known resistance to any of the components of D/C/F/TAF; subjects with known or identified FTC resistance attributed to an M184V mutation alone will be permitted to remain in the study.
- Prior virologic failure on a DRV-containing regimen from known history or from medical records.
- Known history of clinically relevant hepatic disease or hepatitis that in the investigator's judgment is not compatible with D/C/F/TAF.
- Known history of severe hepatic impairment as diagnosed based on documented history of severe hepatic impairment (Child-Pugh C).
- Known history of chronic (≥3 months) renal insufficiency, defined as having an eGFR<30 mL/min according to the MDRD formula.
Show all 16Show fewer
- Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study treatment.
- Plans to father a child while enrolled in this study or within 90 days after the last dose of study treatment.
- Current alcohol or substance use judged by the investigator to potentially interfere with subject study adherence.
- Known history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma.
- Known active, severe infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy that in the judgment of the investigator would increase the risk of morbidity or mortality.
- Any other condition or prior therapy for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the wellbeing) or that could prevent, limit, or confound the protocol-specified assessments.
- Subject unlikely to comply with the protocol requirements based on clinical judgment.
- Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before the planned first dose of study treatment or is currently enrolled in an investigational study.
- Subjects receiving ongoing therapy with contraindicated, not recommended, drugs that cannot be adequately dose-adjusted, or subjects with any known allergies to the excipients of the D/C/F/TAF.
- Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator, or employees of Johnson \& Johnson.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Crofoot Research Center, Inc.
Houston, Texas, 77098
About this study
Official title: A Phase 4, Single-arm, Open-label Study to Evaluate the Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Once Daily Fixed-dose Combination (FDC) Regimen in Antiretroviral Treatment-experienced Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects Not Currently Receiving Any Antiretroviral Therapy.
The purpose of this study is to demonstrate the effectiveness of Symtuza® in a rapid reinitiation model of care in patients with HIV-1 infection and who are treatment-experienced but have been off of antiretroviral therapy (ART) for 12 or more weeks.
Read the detailed description
In the United States, only 49 percent of persons living with HIV infection are currently retained in care (Centers for Disease Control, 2018). Many individuals initially start antiretroviral therapy (ART) but fall out of care and discontinue treatment, only to reenter care at a later date. Gaps in care contribute to the likelihood that a patient might not have a recent viral load or CD4 count, as well as knowledge of previous ART regimens or resistance data. Furthermore, high plasma HIV-1 RNA is a major risk factor for HIV transmission, and effective ART can reduce viremia and transmission of HIV to sexual partners by more than 96% (Cohen et al., 2011; Palella et al., 1998). Thus, a secondary goal of ART is to reduce the risk of HIV transmission.
Traditional models of care have an initial period where a person is brought back into care and assessed by a healthcare provider on various factors, including HIV RNA level, genotypic/ phenotypic resistance, immune status, renal/hepatic function, and general medical comorbidities before reinitiating ART. These steps can add weeks without treatment and, in turn, delay resupression of the virus and immune system improvement, as well as continuing to contribute to the community viral load and offering more opportunities for the person to fall out of care again. (Horburg et al., 2013) This traditional model places a burden on both the patient and the healthcare system as multiple visits are required, each one a potential point where the patient can be lost again to follow-up.
A rapid reinitiation of ART for persons who have fallen out of care is a potential intervention that could improve retention rates, patient satisfaction, and clinical outcomes. Given these factors, the single-tablet regimen of D/C/F/TAF (Symtuza®) may serve as an ideal regimen for a Rapid Reinitiation model of care, combining potency, sustained efficacy, a high genetic barrier to resistance, with a well-described safety profile of the individual components, and practical, convenient dosing.
This prospective, multicenter study will follow subjects for 48 weeks with subjects either returning to the site or having a virtual visit (TeleVisit) for Weeks 2, 4, 12, 24, 36, and 48. Baseline safety labs will dictate whether the ART regimen will need to be modified but will not be required to be completed at the initiation of ART. Assessment of drug accountability, reasons for non-adherence, recording of concomitant therapies, adverse events, weight, physical examinations (complete or symptom-directed), laboratory evaluations (for efficacy and safety), and health outcome assessments will be performed from baseline onwards.
- Conditions
- HIV-1-infection
- Being tested
- Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (FDC)
- Keywords
- Acquired Immunodeficiency Syndrome, HIV Infections, Sexually Transmitted Diseases, Viral, Anti-Retroviral Agents, Antiviral Agents
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections, Sexually Transmitted Diseases, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (FDC)Drug
Participants will receive Symtuza®. An oral tablet containing Darunavir 800 mg /Cobicistat 150 mg /Emtricitabine 200 mg /Tenofovir Alafenamide 10 mg FDC, once daily within 24 hours of the screening/ baseline visit.
| Study group | Role | What they receive |
|---|---|---|
| Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (FDC) | Experimental | Participants will receive oral tablet containing Darunavir 800 milligram (mg)/ Cobicistat 150 mg/ Emtricitabine 200 mg/ Tenofovir Alafenamide 10 mg (D/C/F/TAF) fixed-dose combination (FDC) once daily within 24 hours of the screening/baseline visit. Receives: Drug: Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (FDC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects who have HIV-1 RNA <50 copies/mL at week 48
The proportion of subjects who have HIV-1 RNA <50 copies/mL at week 48 as defined by the FDA snapshot analysis (ITT)
Measured: 48 week
Secondary outcomes (19)
Proportion of subjects who have HIV-1 RNA <50 copies/mL at week 48
Proportion of subjects who have HIV-1 RNA <200 copies/mL at week 48 as defined by the per-protocol (PP) analysis set
Measured: Week 48
Proportion of subjects who have HIV-1 RNA <50 copies/mL at week 48
Proportion of subjects who have HIV-1 RNA <200 copies/mL at week 48 as defined by the FDA snapshot analysis (ITT)
Measured: Week 48
Proportion of subjects who have HIV-1 RNA <200 copies/mL at week 24
Proportion of subjects who have HIV-1 RNA <200 copies/mL at week 24 as defined by the FDA snapshot analysis (ITT)
Measured: Week 24
Change from baseline in HIV-1 RNA viral load
Change from baseline in log10 HIV-1 RNA viral load at Weeks 24 and 48
Measured: Weeks 24 and 48
Change in baseline CD4 cell count
Change in baseline CD4 cell count at Weeks 12, 24, and 48
Measured: Weeks 12, 24, and 48
Discontinuation after enrollment based on study stopping rules
Proportion of subjects that required discontinuation after enrollment based on study stopping rules
Measured: Week 48
Discontinuation due to adverse events
Proportion of subjects discontinuing therapy due to adverse events
Measured: Week 48
Proportion of subjects experiencing grade 3 and 4 adverse events
Proportion of subjects experiencing grade 3 and 4 adverse events
Measured: Week 48
Proportion of subjects experiencing serious adverse events
Proportion of subjects experiencing serious adverse events
Measured: Week 48
Proportion of subjects experiencing grade 3 and 4 laboratory abnormalities
Proportion of subjects experiencing grade 3 and 4 laboratory abnormalities
Measured: Week 48
Proportion of subjects meeting resistance stopping rules requiring discontinuation of study drugs due baseline resistance findings
Proportion of subjects meeting resistance stopping rules requiring discontinuation of study drugs due baseline resistance findings
Measured: Week 48
Proportion of subjects with baseline RT, INI, and PR (primary and secondary) RAMs
Proportion of subjects with baseline RT, INI, and PR (primary and secondary) RAMs
Measured: Week 48
Proportion of subjects developing RAMs and loss of phenotypic susceptibility, when available, upon meeting PDVF
Proportion of subjects developing RAMs and loss of phenotypic susceptibility, when available, upon meeting PDVF
Measured: Week 48
Proportion of subjects with PDVF at Week 24 and Week 48
Proportion of subjects with PDVF at Week 24 and Week 48
Measured: Weeks 24 and 48
Proportion of subjects lost to follow-up throughout the 48 Weeks of treatment
Proportion of subjects lost to follow-up throughout the 48 Weeks of treatment
Measured: Week 48
Proportion of subjects taking study drug at Week 48 who have a documented clinic visit with a healthcare provider within 90 days of Week 48 visit.
Proportion of subjects taking study drug at Week 48 who have a documented clinic visit with a healthcare provider within 90 days of Week 48 visit.
Measured: Week 48
Mean total satisfaction scores on the HIVTSQs at Weeks 4, 24, and 48
Mean total satisfaction scores on the HIVTSQs at Weeks 4, 24, and 48
Measured: Weeks 4, 24, and 48
Mean total depression scores on the PHQ-9 at baseline and Weeks 4, 24, and 48
Mean total depression scores on the PHQ-9 at baseline and Weeks 4, 24, and 48
Measured: Weeks 4, 24, and 48
Adherence as measured by pill count at Weeks 4, 12, 24, and 48
Adherence as measured by pill count at Weeks 4, 12, 24, and 48
Measured: Weeks 4, 12, 24, and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start1 Sep 2021
- Primary completion5 Apr 2024
- Study completion5 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Crofoot Research Center, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Scientific Affairs, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388904
- Sponsor's protocol ID
- TMC114FD2HTX4007
- Acronym
- ReSTART
- Status last verified
- Apr 2024
- First submitted
- 12 May 2020
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Mehendale S, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Wang L, Makhema J, Mills LA, de Bruyn G, Sanne I, Eron J, Gallant J, Havlir D, Swindells S, Ribaudo H, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano D, Essex M, Fleming TR; HPTN 052 Study Team. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011 Aug 11;365(6):493-505. doi: 10.1056/NEJMoa1105243. Epub 2011 Jul 18.
PubMed 21767103Palella FJ Jr, Delaney KM, Moorman AC, Loveless MO, Fuhrer J, Satten GA, Aschman DJ, Holmberg SD. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. N Engl J Med. 1998 Mar 26;338(13):853-60. doi: 10.1056/NEJM199803263381301.
PubMed 9516219Centers for Disease Control and Prevention. Monitoring selected national HIV prevention and care objectives by using HIV surveillance data-United States and 6 dependent areas, 2016. HIV Surveillance Supplemental Report 2018;23(No. 4). http://www.cdc.gov/hiv/library/reports/ hiv-surveillance.html. Accessed [February 4, 2020]
Horberg MA, Hurley LB, Silverberg MJ, Klein DB, Quesenberry CP, Mugavero MJ. Missed office visits and risk of mortality among HIV-infected subjects in a large healthcare system in the United States. AIDS Patient Care STDS. 2013 Aug;27(8):442-9. doi: 10.1089/apc.2013.0073. Epub 2013 Jul 19.
PubMed 23869466
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Single-arm, Open-label Study to Evaluate the Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Once Daily Fixed-dose Combination (FDC) Regimen in Antiretroviral Treatment-experienced Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects Not Currently Receiving Any Antiretroviral Therapy.
- ClinicalTrials.gov ID
- NCT04388904
- Acronym / sponsor ID
- ReSTART / TMC114FD2HTX4007
- Conditions
- HIV-1-infection
- Keywords
- Acquired Immunodeficiency Syndrome, HIV Infections, Sexually Transmitted Diseases, Viral, Anti-Retroviral Agents, Antiviral Agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- The Crofoot Research Center, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Janssen Scientific Affairs, LLC
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 5 Apr 2024 (actual)
- First posted
- 14 May 2020 (actual)
- 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.
The purpose of this study is to demonstrate the effectiveness of Symtuza® in a rapid reinitiation model of care in patients with HIV-1 infection and who are treatment-experienced but have been off of antiretroviral therapy (ART) for 12 or more weeks.
Detailed description
In the United States, only 49 percent of persons living with HIV infection are currently retained in care (Centers for Disease Control, 2018). Many individuals initially start antiretroviral therapy (ART) but fall out of care and discontinue treatment, only to reenter care at a later date. Gaps in care contribute to the likelihood that a patient might not have a recent viral load or CD4 count, as well as knowledge of previous ART regimens or resistance data. Furthermore, high plasma HIV-1 RNA is a major risk factor for HIV transmission, and effective ART can reduce viremia and transmission of HIV to sexual partners by more than 96% (Cohen et al., 2011; Palella et al., 1998). Thus, a secondary goal of ART is to reduce the risk of HIV transmission.
Traditional models of care have an initial period where a person is brought back into care and assessed by a healthcare provider on various factors, including HIV RNA level, genotypic/ phenotypic resistance, immune status, renal/hepatic function, and general medical comorbidities before reinitiating ART. These steps can add weeks without treatment and, in turn, delay resupression of the virus and immune system improvement, as well as continuing to contribute to the community viral load and offering more opportunities for the person to fall out of care again. (Horburg et al., 2013) This traditional model places a burden on both the patient and the healthcare system as multiple visits are required, each one a potential point where the patient can be lost again to follow-up.
A rapid reinitiation of ART for persons who have fallen out of care is a potential intervention that could improve retention rates, patient satisfaction, and clinical outcomes. Given these factors, the single-tablet regimen of D/C/F/TAF (Symtuza®) may serve as an ideal regimen for a Rapid Reinitiation model of care, combining potency, sustained efficacy, a high genetic barrier to resistance, with a well-described safety profile of the individual components, and practical, convenient dosing.
This prospective, multicenter study will follow subjects for 48 weeks with subjects either returning to the site or having a virtual visit (TeleVisit) for Weeks 2, 4, 12, 24, 36, and 48. Baseline safety labs will dictate whether the ART regimen will need to be modified but will not be required to be completed at the initiation of ART. Assessment of drug accountability, reasons for non-adherence, recording of concomitant therapies, adverse events, weight, physical examinations (complete or symptom-directed), laboratory evaluations (for efficacy and safety), and health outcome assessments will be performed from baseline onwards.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (FDC) | Experimental | Drug: Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (FDC)Participants will receive oral tablet containing Darunavir 800 milligram (mg)/ Cobicistat 150 mg/ Emtricitabine 200 mg/ Tenofovir Alafenamide 10 mg (D/C/F/TAF) fixed-dose combination (FDC) once daily within 24 hours of the screening/baseline visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years of age at screening/baseline visit.
- Antiretroviral treatment-experienced and have not received any anti-HIV treatment within 12 weeks prior to screening.
- Contraceptive use by men or women should be consistent with the local regulations regarding the use of contraceptive methods for subject participating in clinical studies.
- Men must agree not to donate sperm during the study until 90 days after receiving the last dose of study drug (or longer, if dictated by local regulations).
- Must be able to swallow whole tablets or swallow tablets cut into halves.
Key exclusion criteria (16 listed)
- Known active cryptococcal infection, active toxoplasmic encephalitis, Mycobacterium tuberculosis infection, or another AIDS-defining condition that in the judgment of the investigator would increase the risk of morbidity or mortality.
- Known resistance to any of the components of D/C/F/TAF; subjects with known or identified FTC resistance attributed to an M184V mutation alone will be permitted to remain in the study.
- Prior virologic failure on a DRV-containing regimen from known history or from medical records.
- Known history of clinically relevant hepatic disease or hepatitis that in the investigator's judgment is not compatible with D/C/F/TAF.
- Known history of severe hepatic impairment as diagnosed based on documented history of severe hepatic impairment (Child-Pugh C).
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 |
|---|---|---|
| Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (FDC)Participants will receive Symtuza®. An oral tablet containing Darunavir 800 mg /Cobicistat 150 mg /Emtricitabine 200 mg /Tenofovir Alafenamide 10 mg FDC, once daily within 24 hours of the screening/ baseline visit. | Drug | Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (FDC) |
Primary outcome
The proportion of subjects who have HIV-1 RNA <50 copies/mL at week 48
Time frame: 48 week
The proportion of subjects who have HIV-1 RNA <50 copies/mL at week 48 as defined by the FDA snapshot analysis (ITT)
19 secondary outcomes
Proportion of subjects who have HIV-1 RNA <50 copies/mL at week 48
Time frame: Week 48
Proportion of subjects who have HIV-1 RNA <50 copies/mL at week 48
Time frame: Week 48
Proportion of subjects who have HIV-1 RNA <200 copies/mL at week 24
Time frame: Week 24
Change from baseline in HIV-1 RNA viral load
Time frame: Weeks 24 and 48
Change in baseline CD4 cell count
Time frame: Weeks 12, 24, and 48
Discontinuation after enrollment based on study stopping rules
Time frame: Week 48
Discontinuation due to adverse events
Time frame: Week 48
Proportion of subjects experiencing grade 3 and 4 adverse events
Time frame: Week 48
Proportion of subjects experiencing serious adverse events
Time frame: Week 48
Proportion of subjects experiencing grade 3 and 4 laboratory abnormalities
Time frame: Week 48
Proportion of subjects meeting resistance stopping rules requiring discontinuation of study drugs due baseline resistance findings
Time frame: Week 48
Proportion of subjects with baseline RT, INI, and PR (primary and secondary) RAMs
Time frame: Week 48
Proportion of subjects developing RAMs and loss of phenotypic susceptibility, when available, upon meeting PDVF
Time frame: Week 48
Proportion of subjects with PDVF at Week 24 and Week 48
Time frame: Weeks 24 and 48
Proportion of subjects lost to follow-up throughout the 48 Weeks of treatment
Time frame: Week 48
Proportion of subjects taking study drug at Week 48 who have a documented clinic visit with a healthcare provider within 90 days of Week 48 visit.
Time frame: Week 48
Mean total satisfaction scores on the HIVTSQs at Weeks 4, 24, and 48
Time frame: Weeks 4, 24, and 48
Mean total depression scores on the PHQ-9 at baseline and Weeks 4, 24, and 48
Time frame: Weeks 4, 24, and 48
Adherence as measured by pill count at Weeks 4, 12, 24, and 48
Time frame: Weeks 4, 12, 24, and 48
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 26 Apr 2024.
- Background: PubMed 21767103Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Mehendale S, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Wang L, Makhema J, Mills LA, de Bruyn G, Sanne I, Eron J, Gallant J, Havlir D, Swindells S, Ribaudo H, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano D, Essex M, Fleming TR; HPTN 052 Study Team. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011 Aug 11;365(6):493-505. doi: 10.1056/NEJMoa1105243. Epub 2011 Jul 18.
- Background: PubMed 9516219Palella FJ Jr, Delaney KM, Moorman AC, Loveless MO, Fuhrer J, Satten GA, Aschman DJ, Holmberg SD. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. N Engl J Med. 1998 Mar 26;338(13):853-60. doi: 10.1056/NEJM199803263381301.
- BackgroundCenters for Disease Control and Prevention. Monitoring selected national HIV prevention and care objectives by using HIV surveillance data-United States and 6 dependent areas, 2016. HIV Surveillance Supplemental Report 2018;23(No. 4). http://www.cdc.gov/hiv/library/reports/ hiv-surveillance.html. Accessed [February 4, 2020]
- Background: PubMed 23869466Horberg MA, Hurley LB, Silverberg MJ, Klein DB, Quesenberry CP, Mugavero MJ. Missed office visits and risk of mortality among HIV-infected subjects in a large healthcare system in the United States. AIDS Patient Care STDS. 2013 Aug;27(8):442-9. doi: 10.1089/apc.2013.0073. Epub 2013 Jul 19.
- Individual participant dataSharing planned: No
Related trials for HIV-1-infection
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
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
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (FDC) in people with HIV-1-infection, run by The Crofoot Research Center, Inc. at 1 site 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 16 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 Apr 2024. 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 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The proportion of subjects who have HIV-1 RNA <50 copies/mL at week 48 (time frame: 48 week). 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 NCT04388904, which also lists 4 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 Apr 2024.