HIV InfectionsNCT03877536
Antiretroviral Therapy for Acute HIV Infection
A study testing Genvoya 150Mg-150Mg-200Mg-10Mg Tablet in people with HIV Infections, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in Uganda.
Trial summary
This study will evaluate the virologic effect, safety and tolerability of Genvoya® in adults during early acute HIV infection. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Genvoya 150Mg-150Mg-200Mg-10Mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUganda
- Study dates
- 17 Mar 2019to 14 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- First identified as an incident HIV infection within one year of estimated time of infection in RV 217.
- Willing to begin Genvoya® as soon as entering this study but not later than 7 days from study enrollment.
- Successfully passed Test of Understanding (TOU) with a score of 80% or more on ten questions after three attempts.
- Adult from 18 to 50 years of age.
- Able to participate for 96 weeks of study visits
- In general good health as determined by the PI or his/her designee
Show all 15Show fewer
- Willing to have photo or fingerprint taken for identification purposes
- No history of ART for any reason, i.e., treatment naïve and no HIV-post-exposure prophylaxis (PEP) or HIV-pre-exposure prophylaxis (PrEP)) within 90 days prior to enrollment
- Willing to have blood samples collected and stored.
- Adequate renal function: estimated creatine clearance of >50 mL/min according to the Cockroft Gault formula 2 weeks prior to enrollment
- Urine clean catch: glucose < trace and protein <1+ or as per site-specification 2 weeks prior to enrollment
- Weight is > 35 kg
- Female (only women of childbearing potential) Specific Criteria:
- Negative pregnancy test 48 hours prior to enrollment:
- Commits to continued use of adequate birth control method for 96 weeks of the study and prior to receiving study ART. Adequate birth control is defined as follows: Contraceptive medications delivered orally, intramuscularly, vaginally, or implanted, underneath the skin, surgical methods (hysterectomy or bilateral tubal ligation), condoms, diaphragms, intrauterine device (IUD), or abstinence. If depending on hormonal contraception, check package insert for drug interactions and/or consider adding a second barrier method.
Who cannot join
- Any chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the volunteer, including but not limited to chronic hepatitis, renal insufficiency or failure; clinically significant forms of drug or alcohol abuse, mental illness, severe asthma, psychiatric disorders, heart disease, or cancer; or a physical finding on examination considered indicative of significant disease such as murmur (other than functional), hepatosplenomegaly, focal neurological deficit, etc.
- Untreated AIDS-related opportunistic infection
- An AIDS defining condition diagnosed within 30 days
- Positive Hepatitis B surface antigen at any time in the past
- Requiring use of any medication that is contraindicated with Genvoya®. See Appendix I and the package insert
- Women who are breast-feeding
- There are no inclusion/exclusion criteria based on CD4 count because CD4 count can be transiently diminished during acute HIV infection and ART initiation during early or acute HIV infection offers the potential benefit of limiting reservoir seeding and preventing immune destruction regardless of peripheral CD4 count at the time of treatment initiation.
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the virologic effect, safety and tolerability of Genvoya® in adults during early acute HIV infection.
Read the detailed description
This is a prospective, open-label study to describe the effects of early antiretroviral (ART) therapy on 1) viral load, 2) safety and tolerability of Genvoya®, 3) clinical outcomes and secondarily on HIV-specific immune responses. This study is a sub-study of RV 217 that will recruit participants with incident HIV diagnoses from the parent RV 217 cohort. Potential RV 392 volunteers will be recruited from the RV 217 ECHO cohort if they have been diagnosed with incident HIV Infection. Screening procedures for HIV in RV 217 are designed to identify participants during acute HIV infection (AHI) or early HIV infection. Participants will initiate Genvoya®, a once a day antiretroviral pill within 1 week of enrollment. RV 392 follow-up visits will largely overlap with RV 217 visits for the study duration of 96 weeks, but additional visits will occur early after initiation of Genvoya®. RV 392 participants will remain co-enrolled in RV 217 (i.e., RV 217 visits also continue); blood collection will be coordinated by the RV 392 team by prioritizing safety labs and then research labs within the allotted blood volumes while still meeting scientific objectives for both RV 217 and RV 392. Blood tests that are required for both protocols will only be collected once and will not be duplicated across the two protocols.
- Conditions
- HIV Infections
- Being tested
- Genvoya 150Mg-150Mg-200Mg-10Mg Tablet
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genvoya 150Mg-150Mg-200Mg-10Mg TabletDrug
Participants will receive 1 tablet per day throughout study duration (96 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Genvoya 150Mg-150Mg-200Mg-10Mg Tablet | Experimental | Genvoya® (Elvitegravir, corbiscistat, Emtricitabine and Tenofovir Alafenamide): once a day antiretroviral pill starting within 1 week of enrollment. Receives: Drug: Genvoya 150Mg-150Mg-200Mg-10Mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma viral load
The number of study participants with plasma viral load <50 copies/mL
Measured: Measured at 48 weeks after enrollment
Plasma viral load
The number of study participants with plasma viral load <50 copies/mL
Measured: Measured at 96 weeks after enrollment
Drug-related AEs and SAEs
Occurrence of drug-related adverse events and serious adverse events at any time from enrollment up to 96 weeks after enrollment early HIV infection.
Measured: Measured through week 96
Treatment Discontinuation for AEs up to 96 weeks
Tolerability of treatment as measured by treatment discontinuation for AEs up to 96 weeks
Measured: Measured through week 96
Secondary outcomes (3)
CD4+ T cell count change
CD4+ T cell count change over first 48 weeks as compared to baseline.following the initiation of Genvoya®
Measured: Measured over 48 weeks
Frequency of HIV-related illnesses
Frequency of HIV-related illnesses (including acute retroviral syndrome)
Measured: Measured through week 96
Duration of HIV-related illnesses
Duration of HIV-related illnesses (including acute retroviral syndrome)
Measured: Measured through week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start17 Mar 2019 (estimated)
- Primary completion14 Sep 2023 (estimated)
- Study completion14 Sep 2025 (estimated)
Why it stopped: Feeder cohort study closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective, open-label study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Christina Polyak, MD, MPH, Study chair, Henry M. Jackson Foundation in support of MHRP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877536
- Sponsor's protocol ID
- RV 392
- Other IDs
- WRAIR 2393
- Status last verified
- Apr 2019
- First submitted
- 26 Sep 2018
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiretroviral Therapy for Acute HIV Infection
- ClinicalTrials.gov ID
- NCT03877536
- Acronym / sponsor ID
- RV 392
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Feeder cohort study closed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 17 Mar 2019 (estimated)
- Primary completion
- 14 Sep 2023 (estimated)
- Study completion
- 14 Sep 2025 (estimated)
- First posted
- 15 Mar 2019 (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.
This study will evaluate the virologic effect, safety and tolerability of Genvoya® in adults during early acute HIV infection.
Detailed description
This is a prospective, open-label study to describe the effects of early antiretroviral (ART) therapy on 1) viral load, 2) safety and tolerability of Genvoya®, 3) clinical outcomes and secondarily on HIV-specific immune responses. This study is a sub-study of RV 217 that will recruit participants with incident HIV diagnoses from the parent RV 217 cohort. Potential RV 392 volunteers will be recruited from the RV 217 ECHO cohort if they have been diagnosed with incident HIV Infection. Screening procedures for HIV in RV 217 are designed to identify participants during acute HIV infection (AHI) or early HIV infection. Participants will initiate Genvoya®, a once a day antiretroviral pill within 1 week of enrollment. RV 392 follow-up visits will largely overlap with RV 217 visits for the study duration of 96 weeks, but additional visits will occur early after initiation of Genvoya®. RV 392 participants will remain co-enrolled in RV 217 (i.e., RV 217 visits also continue); blood collection will be coordinated by the RV 392 team by prioritizing safety labs and then research labs within the allotted blood volumes while still meeting scientific objectives for both RV 217 and RV 392. Blood tests that are required for both protocols will only be collected once and will not be duplicated across the two protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, open-label study
| Arm | Type | Receives |
|---|---|---|
| Genvoya 150Mg-150Mg-200Mg-10Mg Tablet | Experimental | Drug: Genvoya 150Mg-150Mg-200Mg-10Mg TabletGenvoya® (Elvitegravir, corbiscistat, Emtricitabine and Tenofovir Alafenamide): once a day antiretroviral pill starting within 1 week of enrollment. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- First identified as an incident HIV infection within one year of estimated time of infection in RV 217.
- Willing to begin Genvoya® as soon as entering this study but not later than 7 days from study enrollment.
- Successfully passed Test of Understanding (TOU) with a score of 80% or more on ten questions after three attempts.
- Adult from 18 to 50 years of age.
- Able to participate for 96 weeks of study visits
Key exclusion criteria (7 listed)
- Any chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the volunteer, including but not limited to chronic hepatitis, renal insufficiency or failure; clinically significant forms of drug or alcohol abuse, mental illness, severe asthma, psychiatric disorders, heart disease, or cancer; or a physical finding on examination considered indicative of significant disease such as murmur (other than functional), hepatosplenomegaly, focal neurological deficit, etc.
- Untreated AIDS-related opportunistic infection
- An AIDS defining condition diagnosed within 30 days
- Positive Hepatitis B surface antigen at any time in the past
- Requiring use of any medication that is contraindicated with Genvoya®. See Appendix I and the package insert
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 |
|---|---|---|
| Genvoya 150Mg-150Mg-200Mg-10Mg TabletParticipants will receive 1 tablet per day throughout study duration (96 weeks). | Drug | Genvoya 150Mg-150Mg-200Mg-10Mg Tablet |
Primary outcome
Plasma viral load
Time frame: Measured at 48 weeks after enrollment
The number of study participants with plasma viral load <50 copies/mL
Plasma viral load
Time frame: Measured at 96 weeks after enrollment
The number of study participants with plasma viral load <50 copies/mL
Drug-related AEs and SAEs
Time frame: Measured through week 96
Occurrence of drug-related adverse events and serious adverse events at any time from enrollment up to 96 weeks after enrollment early HIV infection.
Treatment Discontinuation for AEs up to 96 weeks
Time frame: Measured through week 96
Tolerability of treatment as measured by treatment discontinuation for AEs up to 96 weeks
3 secondary outcomes
CD4+ T cell count change
Time frame: Measured over 48 weeks
Frequency of HIV-related illnesses
Time frame: Measured through week 96
Duration of HIV-related illnesses
Time frame: Measured through week 96
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- 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.
Christina Polyak, MD, MPH study chair
Henry M. Jackson Foundation in support of MHRP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genvoya 150Mg-150Mg-200Mg-10Mg Tablet in people with HIV Infections, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 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: withdrawn, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Plasma viral load (time frame: Measured at 48 weeks after enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2019.