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Antiretroviral Therapy
Arm A: Rapid Start Group for HIV/AIDS (B-HASTE Trial)
Phase 4
Waitlist Available
Led By Hillary Dunlevy, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights
B-HASTE Trial Summary
This trial will compare starting HIV treatment immediately to waiting until later.
Eligible Conditions
- HIV/AIDS
B-HASTE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Viral Suppression
B-HASTE Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Arm A: Rapid Start GroupActive Control1 Intervention
Same day antiretroviral therapy (ART) with bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) + new diagnosis package with laboratory evaluations and social work referral.
Group II: Arm B: Standard GroupPlacebo Group1 Intervention
Standard initiation of ART at the discretion of provider + new diagnosis package with laboratory evaluations and social work referral.
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,732 Previous Clinical Trials
2,143,538 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,082 Previous Clinical Trials
842,831 Total Patients Enrolled
Hillary Dunlevy, MDPrincipal InvestigatorUniversity of Colorado, Denver
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Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Rapid Start Group
- Group 2: Arm B: Standard Group
Awards:
This trial has 4 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
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