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Antiretroviral Therapy
Antiretroviral Therapy for Early HIV/AIDS (DGVTAF Trial)
Phase 4
Waitlist Available
Led By Sulggi Lee, MD PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Acute HIV infection with a negative or indeterminate HIV-1 antibody test and plasma HIV-1 RNA > 40 cp/ml, OR clinical history consistent with new HIV infection in the last 90 days
Participant must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
DGVTAF Trial Summary
This trial will test whether a treatment regimen of dolutegravir and emtricitabine/tenofovir can protect immune cells in people with very early HIV infection.
Who is the study for?
This trial is for adults over 18 with very early HIV infection (within the last 90 days), who haven't started or have just begun antiretroviral therapy. Participants must consent to study procedures, not be trying to conceive, and use double contraception when sexually active.Check my eligibility
What is being tested?
The trial tests if starting a combination of dolutegravir and emtricitabine/tenofovir right after HIV infection helps protect immune cells. It aims to treat participants at the 'hyperacute' stage of HIV.See study design
What are the potential side effects?
Potential side effects may include headache, diarrhea, nausea, fatigue, allergic reactions, and possible liver or kidney problems. Specific side effects depend on individual health conditions.
DGVTAF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have recently been diagnosed with HIV, with specific test results or symptoms.
Select...
I can follow the medication schedule and attend all study visits.
DGVTAF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and tolerability of immediate Dolutegravir plus Emtricitabine/Tenofovir administered to acutely infected HIV patients.
Secondary outcome measures
Body Weight Changes
Change in HIV reservoir size (cell-associated total DNA) in peripheral blood
Change in HIV reservoir size (cell-associated unspliced RNA) in peripheral blood
Other outcome measures
Change in HIV reservoir size (cell-associated integrated DNA) in GALT CD4+ subsets
Change in HIV reservoir size (cell-associated integrated DNA) in blood CD4+ subsets
Body Weight Changes
+3 moreDGVTAF Trial Design
1Treatment groups
Experimental Treatment
Group I: Dolutegravir+Emtricitabine/TenofovirExperimental Treatment2 Interventions
Dolutegravir 50 mg PO daily plus Emtricitabine 200 mg/Tenofovir alafenamide 25 mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dolutegravir
2018
Completed Phase 4
~5970
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,505 Previous Clinical Trials
15,237,481 Total Patients Enrolled
ViiV HealthcareIndustry Sponsor
360 Previous Clinical Trials
468,505 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,082 Previous Clinical Trials
842,625 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is severely impaired.I can follow the medication schedule and attend all study visits.I will use two forms of birth control for two weeks after stopping the study drug.My liver condition is stable and I don't have serious gallbladder issues.I haven't been hospitalized or needed treatment for a serious illness in the last 3 months.I am 18 years old or older.I have either not started antiretroviral therapy or began it within the last 7 days.I have severe liver problems.I expect to need treatment for Hepatitis C during the study.I am not taking dofetilide, oxcarbazepine, phenytoin, phenobarbital, carbamazepine, St. John's wort, or metformin.I haven't taken any immune system affecting drugs in the last 3 months.I have not taken any experimental drugs in the last 90 days.I can't stop my blood thinners for biopsies due to a clotting disorder.I do not have inflammatory bowel conditions like Crohn's or ulcerative colitis, and no recent major bowel surgeries.I have recently been diagnosed with HIV, with specific test results or symptoms.
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants being sought for this medical experiment?
"Investigations on clinicaltrials.gov reveal that this research project is no longer recruiting patients, having been initially posted on December 1st 2015 and last edited on July 7th 2022. However, 1439 other trials are currently open for enrollment."
Answered by AI
Has the federal agency accepted Emtricitabine/Tenofovir as a legitimate therapeutic?
"Given the advanced stage of clinical trials, our team at Power rated Emtricitabine/Tenofovir '3' on a 1-3 scale in terms of safety. This reflects that it is approved for use and has undergone multiple rounds of data collection to support its efficacy."
Answered by AI
What therapeutic purpose does Emtricitabine/Tenofovir typically serve?
"Emtricitabine/Tenofovir is commonly applied to combat HIV-1, as well as hinder the spread of HIV and treat other related infections."
Answered by AI
What is the current threshold for enrollment in this medical experiment?
"Unfortunately, this medical trial has ceased accepting new participants. Initially posted on December 1st 2015 and last updated July 7th 2022, it is not the best option for someone seeking to join a research study. There are other possibilities available; 1323 HIV related studies and 116 trials using Emtricitabine/Tenofovir presently have open slots."
Answered by AI
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