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Combination Intervention

Phase 1

HIV/AIDS | Small molecule | Infectious Disease |GeoVax Labs, Inc.|Last Updated: Feb 24, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment11

FDA Designations

No designations recorded

Clinical trial landscape

Combination Intervention · 1 trial · 1 indication

Phase 1 1
NCT04357821Combinatorial Therapy to Induce an HIV RemissionHIV/AIDS
ACTIVE NOT_RECRUITING11 Analytics
PHASE1ACTIVE NOT_RECRUITING
Combinatorial Therapy to Induce an HIV Remission
HIV/AIDS
NCT0435782111
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Study Endpoints

Primary Endpoints

Grade 3 or Greater Adverse Event Count
Week 0 through 102

Number of participants who experience a new grade 3 or greater adverse event

Proportion of Participants Achieving Post-treatment Control
Week 34 through 86

This will be defined as: 1. Participants who fail to show any consistent rebound above 400 copies RNA/mL between Week 12 of the ATI (when bNAb levels wane) and Week 36 of the ATI 2. Participants who exhibit a rebound and eventually achieve 24 weeks of virus control will be considered as having achieved post-treatment control

Secondary Endpoints

Any Grade 2, 3 or 4 Adverse Event Through Week 62
Week 0 through 62
Any Serious Adverse Events, Medically Attended Adverse Event, and Potentially Immune-mediated Medical Condition
Week 0 through 86
Magnitude of T Cell Responses
Week 22
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Combination intervention armEXPERIMENTALAll volunteers will receive the combination intervention outlined above.

Interventions

NameTypeDescription
Combination InterventionDRUG1. IL-12 adjuvanted p24CE DNA prime (p24CE/IL-12) at Weeks 0 and 4 2. IL-12 adjuvanted DNA boost (p24CE plus p55gag) at Week 12 3. MVA/HIV62B (MVA62B) boost at Week 20 4. single dose of two bNAbs (VRC07-523LS and 10-1074, which target CD4 binding site and V3 loop, respectively) at week 24 with a TLR9 agonist (lefitolimod) administered weekly between Weeks 24 and 33 (10 doses) 5. ATI with single dose of VRC07 and 10-1074 at Week 34
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Eligibility Criteria

Age Range18 Years to 67 Years
SexALL
Healthy VolunteersNo
Study Sites1

Key Inclusion Criteria 1. Willing and able to provide written informed consent. 2. 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. 3. Documented HIV-1 infection. 4. On continuous ...

Countries:United States
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Frequently asked questions about Combination Intervention

What is Combination Intervention used for in HIV/AIDS?

Combination Intervention is an investigational small molecule being studied for the treatment of HIV/AIDS. It is currently in Phase 1 clinical development, with the goal of inducing HIV remission. The drug is being evaluated in a single active clinical trial in the United States.

Who makes Combination Intervention?

Combination Intervention is being developed by GeoVax Labs, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GOVX. The company is conducting a Phase 1 clinical trial to evaluate the drug's safety and efficacy in patients with HIV/AIDS.

What phase is Combination Intervention in?

Combination Intervention is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness for the treatment of HIV/AIDS.

What clinical trials is Combination Intervention in?

Combination Intervention is being studied in a Phase 1 clinical trial with the identifier NCT04357821, titled 'Combinatorial Therapy to Induce an HIV Remission.' This active, non-recruiting trial is enrolling 11 participants with HIV/AIDS in the United States and is not randomized or blinded.

Is Combination Intervention the same as a combinatorial therapy?

Combination Intervention refers to a combinatorial therapy approach being tested for HIV remission. The ongoing Phase 1 trial, NCT04357821, is titled 'Combinatorial Therapy to Induce an HIV Remission,' indicating that the intervention involves a combination of agents rather than a single drug.