Early ART for HIV

(EARLIER Trial)

No longer recruiting at 38 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Must be taking: Antiretrovirals

Must not be taking: Steroids, Cancer chemotherapy

Disqualifiers: Positive HIV-1 antibody, Drug dependence, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the benefits of starting antiretroviral therapy (ART) soon after an HIV-1 diagnosis. Researchers aim to determine how early ART initiation affects virus levels in the blood and the immune system's ability to combat the infection. The study includes different groups based on how recently participants were infected and their current HIV test results. Suitable candidates for this trial are those recently diagnosed with acute HIV-1 infection and possessing specific types of HIV test results. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does mention that chronic or recurrent use of medications that modify the immune response, like steroids or cancer chemotherapy, may exclude you from participating. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that the combination of bictegravir, emtricitabine, and tenofovir alafenamide was well-tolerated by people with HIV-1. Most participants experienced good virus control with few side effects, and serious side effects were rare. Another treatment, which includes elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide, also demonstrated a good safety record. Research showed that this treatment was generally well-tolerated, with serious side effects being uncommon. Both treatments have approval for other uses, indicating their safety for people considering joining this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer a potential for early intervention in HIV infection, specifically targeting the virus during its initial stages. Unlike standard treatments that are usually started once the infection is more established, these combinations aim to suppress the virus right from the early Fiebig stages, which could prevent further progression and limit long-term damage to the immune system. The use of combinations like bictegravir/emtricitabine/tenofovir alafenamide and elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in the early stages is promising due to their potent antiviral activity and relatively favorable side-effect profiles, providing a comprehensive approach to managing HIV early on.

What evidence suggests that this trial's treatments could be effective for early HIV treatment?

This trial will evaluate the effectiveness of two treatment combinations for HIV. Studies have shown that bictegravir/emtricitabine/tenofovir alafenamide, a potential treatment for participants, effectively lowers HIV levels in the blood and is generally safe with few side effects. Meanwhile, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, another option in this trial, reduces the virus to undetectable levels. Previous findings indicate that both treatments help the immune system fight HIV effectively. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals recently diagnosed with acute HIV-1 infection who can start treatment immediately and are willing to follow the study plan for up to 72 weeks. Women of childbearing potential must use contraception, and participants should not have any health conditions that could affect their participation or be on immune-modifying drugs.

Inclusion Criteria

I have discussed the safety of my ARV regimen during pregnancy with my doctor.

I am ready and willing to start antiretroviral therapy at enrollment.

I am a woman capable of becoming pregnant.

Exclusion Criteria

Any acute, chronic, or recent and clinically significant medical condition that, in the opinion of the site investigator, would interfere with adherence to study requirements or jeopardize the safety or rights of the participant

I haven't used HIV prevention drugs in the 60 days before my acute HIV infection diagnosis.

I regularly take medication that affects my immune system, like steroids.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment (Step 1)

Immediate initiation of ART for participants diagnosed with acute HIV-1 infection

72 weeks

Evaluations at weeks 2 and 8 via telephone

Follow-up (Step 2)

Long-term follow-up to expand the number of available participants for future studies

144 weeks

What Are the Treatments Tested in This Trial?

Interventions

• bictegravir/emtricitabine/tenofovir alafenamide
• elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide

Trial Overview The trial tests early antiretroviral therapy (ART) using FDA-approved medications like elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide among others. It aims to see how early ART affects HIV-1 levels in blood, the body's response, and the amount of virus in CD4+ T-cells after 48 weeks.

How Is the Trial Designed?

Group I: Arm 3: Fiebig V Experimental Treatment 1 Intervention

Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).

Group II: Arm 2: Fiebig III/IV Experimental Treatment 1 Intervention

Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).

Group III: Arm 1: Fiebig I/II Experimental Treatment 1 Intervention

Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).

bictegravir/emtricitabine/tenofovir alafenamide is already approved in European Union, United States, Canada, Japan, Switzerland for the following indications:

Approved in European Union as Biktarvy for:

• HIV-1 infection

Approved in United States as Biktarvy for:

• HIV-1 infection

Approved in Canada as Biktarvy for:

• HIV-1 infection

Approved in Japan as Biktarvy for:

• HIV-1 infection

Approved in Switzerland as Biktarvy for:

• HIV-1 infection

Who Is Running the Clinical Trial?

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Lead Sponsor

Trials

103

Recruited

74,200+

AIDS Clinical Trials Group

Lead Sponsor

Trials

101

Recruited

73,600+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10003752/

Effectiveness and Safety of Bictegravir/Emtricitabine ... Use of bictegravir/emtricitabine/tenofovir alafenamide among people with HIV and substance use disorder was safe and effective, with low rates of emergent HIV ...

2. academic.oup.com academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaf162/8098170

Real-world Effectiveness and Safety of Bictegravir ... This study compares bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) with other first-line antiretroviral therapies in treatment-naive adults.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12151942/

Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide ... In people with HIV (PWH) experiencing viremia, guidelines recommend the continuation of antiretroviral therapy (ART) and support to increase ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02607930?tab=results

NCT02607930 | Study to Evaluate the Safety and Efficacy ... Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) shows high efficacy in clinical study participants infected with HIV-1 subtype F. [Poster P124]. HIV ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S092485792300290X

Effectiveness and safety of bictegravir/emtricitabine ... As initial therapy, BIC in combination with emtricitabine and tenofovir alafenamide (BIC/FTC/TAF) has demonstrated high efficacy and a favourable safety and ...

6. ema.europa.eu ema.europa.eu/en/documents/product-information/biktarvy-epar-product-information_en.pdf

Biktarvy, INN-bictegravir / emtricitabine / tenofovir alafenamide There are limited safety and efficacy data for Biktarvy in patients co-infected with HIV-1 and hepatitis C virus (HCV). Biktarvy contains tenofovir alafenamide, ...

7. academic.oup.com academic.oup.com/ofid/article/11/11/ofae630/7826499

Effectiveness and Safety of Bictegravir/Emtricitabine/Tenofovir ... BIC/FTC/TAF demonstrated robust virologic suppression and tolerability in patients presenting late in the course of HIV infection.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10693755/

Bictegravir/Emtricitabine/Tenofovir Alafenamide for HIV-1 This review presents recent literature supporting the use of B/F/TAF as an option for consolidating therapy and maintaining virologic suppression.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT02607956

NCT02607956 | Study to Evaluate the Safety and Efficacy ... Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) shows high efficacy in clinical study participants infected with HIV-1 subtype F. [Poster P124]. HIV ...

10. biktarvy.com biktarvy.com/

BIKTARVY® | A One-Pill, Once-a-Day Treatment Option BIKTARVY does not cure HIV-1 or AIDS. HIV-1 is the virus that causes AIDS. Tap for Important Safety Information for BIKTARVY, including an important warning on ...