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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 belowSelect...
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:Select...
I have an active hepatitis C infection.
Select...
My tests show high resistance to specific treatments.
Select...
I am taking medication that is not a non-nucleoside reverse transcriptase inhibitor.
Select...
I have had cancer linked to HIV, like Kaposi's sarcoma or lymphoma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 34 through 86
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 34 through 86
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
51 Previous Clinical Trials
13,505 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,336 Previous Clinical Trials
5,382,823 Total Patients Enrolled
GeoVax, Inc.Industry Sponsor
5 Previous Clinical Trials
424 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,593 Previous Clinical Trials
14,887,939 Total Patients Enrolled
amfAR, The Foundation for AIDS ResearchOTHER
28 Previous Clinical Trials
6,144 Total Patients Enrolled
Rockefeller UniversityOTHER
160 Previous Clinical Trials
16,515 Total Patients Enrolled
Ichor Medical Systems IncorporatedIndustry Sponsor
10 Previous Clinical Trials
428 Total Patients Enrolled
Ichor Medical SystemsUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an active hepatitis C infection.I haven't had or expected to have cancer treatment, except for HIV-related, in the last 3 years.My tests show high resistance to specific treatments.I am 67 or younger, starting treatment early, or under 65 if starting late.I have a history of immune conditions, but not just Raynaud's or issues treated with creams only.I am taking medication that is not a non-nucleoside reverse transcriptase inhibitor.I have had cancer linked to HIV, like Kaposi's sarcoma or lymphoma.I've been on stable HIV treatment without NNRTIs for over a year without breaks longer than 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Combination intervention arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
HIV/AIDS Patient Testimony for trial: Trial Name: NCT04357821 — Phase 1 & 2