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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
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
Be older than 18 years old
Must not have
Active hepatitis C (HCV) infection
High-level resistance to both 10-1074 and VRC-07 as defined using the PhenoSense Neutralizing Antibody Assay (Monogram Biosciences)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 34 through 86
Awards & highlights
No Placebo-Only Group

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.
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.
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've been on stable HIV treatment without NNRTIs for over a year without breaks longer than 2 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an active hepatitis C infection.
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My tests show high resistance to specific treatments.
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I am taking medication that is not a non-nucleoside reverse transcriptase inhibitor.
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I have had cancer linked to HIV, like Kaposi's sarcoma or lymphoma.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of participants achieving post-treatment control.
Secondary study objectives
Breadth of T cell responses

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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?

Mologen AGIndustry Sponsor
6 Previous Clinical Trials
763 Total Patients Enrolled
International AIDS Vaccine InitiativeNETWORK
50 Previous Clinical Trials
13,409 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,316 Previous Clinical Trials
5,547,737 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
~0 spots leftby Dec 2024
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