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Antiretroviral Therapy

Combination Therapy for HIV/AIDS

Phase 1 & 2
Waitlist Available
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
Age ≤67 years at the time of enrollment for those who started treatment during early infection and <65 years for those who started treatment during chronic infection
On continuous antiretroviral therapy for at least 12 months without any interruptions of greater than 14 consecutive days within the last 1 year, and on a stable regimen that does not include a non-nucleoside reverse transcriptase inhibitor (NNRTI) for at least 4 weeks, without plans to modify ART during the study period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 34 to 86
Awards & highlights

Study Summary

This trial will study whether a combination of different drugs can help control HIV in people who stop taking antiretroviral therapy (ART).

Who is the study for?
This trial is for adults under 67 with HIV who've been on stable antiretroviral therapy without interruptions for at least a year. They must have a strong immune system (CD4+ T-cell count ≥ 500 cells/mm3) and undetectable HIV levels for the past two years. Excluded are those with certain medical conditions, recent cancers, low CD4+ counts during chronic infection phase, active hepatitis B or C, pregnancy, or resistance to specific antibodies.Check my eligibility
What is being tested?
The study tests a combination treatment aimed at controlling HIV without ongoing medication. Twenty participants will receive this regimen while on their usual antiretroviral therapy (ART), followed by a period where ART is paused to see if the virus remains controlled.See study design
What are the potential side effects?
Potential side effects aren't specified but may include reactions related to immune activation or suppression due to the combination therapy and risks associated with stopping standard ART during the trial's analytic treatment interruption phase.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 67 or younger, starting treatment early, or under 65 if starting late.
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I've been on stable HIV treatment without NNRTIs for over a year without breaks longer than 2 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 34 to 86
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 34 to 86 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants achieving post-treatment control.
Proportion of participants who experience a new grade 3 or greater adverse event
Secondary outcome measures
Breadth of T cell responses
Frequency of confirmed declines (two consecutive measurements) in CD4+ T cell counts (> 50%)
Frequency of confirmed declines (two consecutive measurements) to below 350 cells/mm3
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Combination intervention armExperimental Treatment1 Intervention
All volunteers will receive the combination intervention outlined above.

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,261 Previous Clinical Trials
5,483,091 Total Patients Enrolled
GeoVax, Inc.Industry Sponsor
5 Previous Clinical Trials
496 Total Patients Enrolled
International AIDS Vaccine InitiativeNETWORK
48 Previous Clinical Trials
13,249 Total Patients Enrolled

Media Library

Combination Intervention (Antiretroviral Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04357821 — Phase 1 & 2
HIV/AIDS Research Study Groups: Combination intervention arm
HIV/AIDS Clinical Trial 2023: Combination Intervention Highlights & Side Effects. Trial Name: NCT04357821 — Phase 1 & 2
Combination Intervention (Antiretroviral Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04357821 — Phase 1 & 2
HIV/AIDS Patient Testimony for trial: Trial Name: NCT04357821 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical experiment currently seeking participants?

"According to the information presented on clinicaltrials.gov, this medical trial is now closed for enrollment. It was initially suggested on August 1st 2020 and had its most recent update released on March 21st 2022. Currently, there are 515 other trials actively recruiting participants from around the world."

Answered by AI

Does the eligibility for this trial extend to individuals below 25 years of age?

"Eligible candidates for this medical trial must be between 18 and 67 years old. For those under 18, there are 113 other clinical trials available; additionally, 379 studies exist specifically tailored to senior citizens."

Answered by AI

Who is the ideal candidate for this research project?

"This clinical trial is searching for 11 individuals with Acquired Immunodeficiency Syndrome (AIDS) who are aged between 18 and 67. To be eligible, patients must have been receiving antiretroviral therapy without any interruptions of greater than 14 consecutive days within the last year on a stable regimen that does not include a non-nucleoside reverse transcriptase inhibitor (NNRTI). Additionally, those being treated during early infection can only apply if they are ≤67 years at time of enrollment whereas those starting treatment in chronic infection must be <65 years old."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Zuckerberg San Francisco General Hospital, University of California San Francisco
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have a problem taking my meds regularly and feel this study may help me in a healthy way.
PatientReceived 2+ prior treatments
~2 spots leftby Dec 2024