Apply to Trial

Compensation: Varies

Number of Visits: Unknown

Duration: 34 weeks

11 Participants Needed

Combination Therapy for HIV/AIDS

Overseen BySteven G Deeks, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of California, San Francisco

Must be taking: Antiretrovirals

Must not be taking: Non-nucleoside reverse transcriptase inhibitors

Disqualifiers: Pregnancy, HIV malignancy, Hepatitis B, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Combination approaches will almost certainly be required to generate durable control of HIV in the absence of antiretroviral therapy (a "remission"). In this study, 20 individuals will receive a combination regimen administered during ART and then undergo an analytic treatment interruption (ATI).

Will I have to stop taking my current medications?

The trial requires participants to stay on their current antiretroviral therapy (ART) without changes during the study period, as long as it does not include a non-nucleoside reverse transcriptase inhibitor (NNRTI).

Is combination therapy for HIV/AIDS generally safe for humans?

Combination therapy for HIV/AIDS, which includes various antiretroviral drugs, is generally safe but can have side effects like kidney and bone issues or mental health effects. These side effects can affect how well people stick to their treatment, so it's important to consider safety when choosing a therapy plan.¹ ² ³ ⁴ ⁵

How is the combination therapy for HIV/AIDS different from other treatments?

The combination therapy for HIV/AIDS is unique because it uses multiple drugs together to enhance antiviral effects, reduce the chance of the virus becoming resistant, and cover a broader range of virus types and tissue areas. This approach can lead to better suppression of the virus and improved treatment outcomes compared to using single drugs.³ ⁶ ⁷ ⁸ ⁹

What data supports the effectiveness of the drug Combination Intervention for HIV/AIDS?

Research shows that using a combination of antiretroviral drugs, like zidovudine, lamivudine, and a protease inhibitor such as indinavir, can be more effective than using a single drug. These combinations help control the virus better and reduce the chance of the virus becoming resistant to treatment.⁷ ⁸ ¹⁰ ¹¹ ¹²

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am 67 or younger, starting treatment early, or under 65 if starting late.

Willing and able to provide written informed consent

Documented HIV-1 infection

See 3 more

Exclusion 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.

See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a combination regimen including IL-12 adjuvanted p24CE DNA prime, DNA boost, MVA/HIV62B boost, bNAbs, and TLR9 agonist

34 weeks

Multiple visits for administration of vaccines and antibodies

Analytic Treatment Interruption (ATI)

Participants undergo ATI with monitoring of viral load and administration of bNAbs

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment interruption

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

Combination Intervention

Trial Overview 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.

How Is the Trial Designed?

1Treatment groups

Experimental Treatment

Group I: Combination intervention armExperimental Treatment1 Intervention

All volunteers will receive the combination intervention outlined above.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Mologen AG

Industry Sponsor

Trials

Recruited

770+

International AIDS Vaccine Initiative

Collaborator

Trials

Recruited

13,300+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

GeoVax, Inc.

Industry Sponsor

Trials

Recruited

440+

amfAR, The Foundation for AIDS Research

Collaborator

Trials

Recruited

6,200+

Rockefeller University

Collaborator

Trials

162

Recruited

16,700+

Ichor Medical Systems Incorporated

Industry Sponsor

Trials

Recruited

440+

Ichor Medical Systems

Collaborator

Trials

Recruited

10+

Published Research Related to This Trial

In a study of 1160 patients on antiretroviral treatment for HIV-1, 47% experienced clinical adverse events and 27% had laboratory adverse events linked to their treatment, highlighting a significant prevalence of side effects.

The research found that more complex treatment regimens, such as dual-PI and three-class antiretroviral treatments, were associated with a higher likelihood of adverse events compared to simpler single-PI treatments, indicating the need for careful monitoring of patients on these regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of adverse events associated with potent antiretroviral treatment: Swiss HIV Cohort Study.Fellay, J., Boubaker, K., Ledergerber, B., et al.[2022]