BMS-663068 for HIV

Recruiting at 130 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: ViiV Healthcare

Must be taking: Antiretrovirals

Disqualifiers: Untreated Hepatitis B, HIV-2, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

371 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop your current medications. However, it mentions that participants must be failing their current antiretroviral regimen, which might imply changes to your treatment plan.

What data supports the effectiveness of the drug BMS-663068 for HIV?

Research shows that BMS-663068, which helps prevent the HIV virus from attaching to cells, led to a significant reduction in the virus in the blood of patients. In a study, the drug's effectiveness was similar to another HIV treatment, atazanavir/ritonavir, in patients who had previous HIV treatments. ^{1 2 3 4 5}

What is known about the safety of BMS-663068 for humans?

BMS-663068, tested in HIV-1-infected individuals, has been evaluated for safety in a Phase IIb trial, showing consistent response rates compared to another treatment, atazanavir/ritonavir, over 24 weeks. This suggests it has a safety profile comparable to existing treatments for HIV. ^{1 2 3 4 5}

What makes the drug BMS-663068 unique for treating HIV?

BMS-663068 is unique because it is an oral drug that works by preventing the HIV virus from attaching to and entering CD4 T-cells, which is different from many other HIV treatments that target the virus after it has already entered the cells. ^{1 2 3 4 5}

What is the purpose of this trial?

The purpose of this study is to determine whether the BMS Attachment Inhibitor (BMS-663068) is effective in the treatment of heavily treatment experienced HIV-1 patients with multi-drug resistance.

Research Team

GSK Clinical Trials

Principal Investigator

ViiV Healthcare

Eligibility Criteria

This trial is for adults with chronic HIV-1 who have tried several antiretroviral drugs without success, showing resistance or intolerance to at least three drug classes. They must be failing their current regimen and have limited options left, but still able to take at least one effective antiretroviral.

Inclusion Criteria

My current HIV treatment is not working, with a viral load over 400 c/mL.

I have limited HIV medication options due to resistance but can combine 1-2 effective drugs.

I can start taking an approved HIV medication from Day 9 in the study.

Exclusion Criteria

I have chronic Hepatitis B but am receiving treatment for it.

I am infected with HIV-2.

Alkaline Phosphatase > 5 x ULN

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants receive BMS-663068 600 mg tablets orally twice daily for 8 days

1 week

Daily visits for medication administration

Treatment Phase 2

Participants receive BMS-663068 600 mg tablets orally twice daily for 48 weeks or longer

48 weeks

Regular visits for monitoring and medication

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants may continue receiving fostemsavir during the open-label period

Up to Week 96

Treatment Details

Interventions

• BMS-663068

Trial Overview The study tests BMS-663068, a new potential treatment for HIV-1 in patients who've had little success with other treatments due to multi-drug resistance. Participants will either receive this experimental drug or a placebo alongside their standard care.

Participant Groups

Group I: BMS-663068 Experimental Treatment 1 Intervention

BMS-663068 600 mg tablets orally twice daily for 48 weeks or longer.

Group II: A1: BMS-663068 Experimental Treatment 1 Intervention

Phase 1: BMS-663068 600 mg tablets orally twice daily for 8 days. Phase 2: BMS-663068 600 mg tablets orally twice daily for 48 weeks or longer.

Group III: B1: Placebo + BMS-663068 Active Control 2 Interventions

Phase 1: Placebo twice daily for 8 days. Phase 2: BMS-663068 600 mg tablets orally twice daily for 48 weeks or longer.

Who Is Running the Clinical Trial?

ViiV Healthcare

Lead Sponsor

Trials

379

Recruited

479,000+

Founded

2009

Headquarters

London, England, UK

Known For

HIV Research

Top Products

- Tivicay (dolutegravir), - Triumeq (abacavir/dolutegravir/lamivudine), - Juluca (dolutegravir/rilpivirine), - Apretude (cabotegravir)

Dr. Harmony Garges

ViiV Healthcare

Chief Medical Officer

MD

Deborah Waterhouse

ViiV Healthcare

Chief Executive Officer since 2017

Bachelor's degree in Business Administration

Findings from Research

BMS-663068, an HIV attachment inhibitor, was well tolerated in a Phase IIb trial with 251 treatment-experienced HIV-1-positive subjects, showing no serious adverse events or discontinuations related to the drug.

The safety profile of BMS-663068 was favorable compared to atazanavir/ritonavir, with significantly fewer drug-related adverse events (8.5% vs. 27.5%), indicating its potential as a safe alternative in HIV treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of HIV-1 attachment inhibitor prodrug BMS-663068 in antiretroviral-experienced subjects: week 24 analysis. Lalezari, J., Latiff, GH., Brinson, C., et al.[2018]

BMS-663068, an attachment inhibitor for HIV-1, showed comparable virologic response rates to atazanavir/ritonavir (ATV/r) in treatment-experienced HIV-1-positive subjects, indicating its potential as an effective alternative treatment.

The study, involving 251 participants, demonstrated similar increases in CD4+ T-cell counts across all treatment arms, suggesting that BMS-663068 is as safe and effective as ATV/r in improving immune function in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV-1 attachment inhibitor prodrug BMS-663068 in antiretroviral-experienced subjects: week 24 sub-group analysis. Brinson, C., Lalezari, J., Gulam, LH., et al.[2018]

BMS-663068, an oral prodrug for HIV treatment, showed promising efficacy with 80% of patients on the 400 mg twice daily dose achieving an HIV-1 RNA viral load of less than 50 copies per mL at week 24, comparable to the 75% response rate in the ritonavir-boosted atazanavir group.

The safety profile of BMS-663068 was favorable, with no serious adverse events linked to the drug and a lower incidence of grade 2-4 adverse events compared to ritonavir-boosted atazanavir, suggesting it is a viable option for treatment-experienced HIV-1 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of the HIV-1 attachment inhibitor prodrug BMS-663068 in treatment-experienced individuals: 24 week results of AI438011, a phase 2b, randomised controlled trial. Lalezari, JP., Latiff, GH., Brinson, C., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Prediction of virological response and assessment of resistance emergence to the HIV-1 attachment inhibitor BMS-626529 during 8-day monotherapy with its prodrug BMS-663068. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Pharmacodynamics, safety, and pharmacokinetics of BMS-663068, an oral HIV-1 attachment inhibitor in HIV-1-infected subjects. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Safety profile of HIV-1 attachment inhibitor prodrug BMS-663068 in antiretroviral-experienced subjects: week 24 analysis. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

HIV-1 attachment inhibitor prodrug BMS-663068 in antiretroviral-experienced subjects: week 24 sub-group analysis. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and efficacy of the HIV-1 attachment inhibitor prodrug BMS-663068 in treatment-experienced individuals: 24 week results of AI438011, a phase 2b, randomised controlled trial. [2019]