BMS-663068 for HIV

Not currently recruiting at 147 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called BMS-663068, an experimental drug, to determine its effectiveness for people with HIV who have not succeeded with many other treatments. The focus is on individuals who have developed resistance to multiple HIV medications and are not responding to their current treatments. Participants should have lived with HIV for some time and experienced issues with at least three classes of HIV medications. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants access to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that BMS-663068 is likely to be safe for humans?

Research has shown that BMS-663068 is safe for humans. In earlier studies, people who took BMS-663068 for eight days experienced lower HIV levels. The treatment was generally well-tolerated, causing no major side effects for most participants. Another study found similar results, with participants reporting a good safety experience. While these studies provide promising safety information, ongoing research continues to assess the long-term safety and effectiveness of this treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for HIV?

BMS-663068 is unique because it offers a fresh approach to HIV treatment by targeting the virus in a new way. Unlike typical antiretroviral therapies that inhibit enzymes like reverse transcriptase or protease, BMS-663068 works by blocking the virus's entry into cells, which is a novel mechanism of action. This entry inhibitor could potentially offer a solution for patients who have developed resistance to existing therapies, making it a promising option in the fight against HIV. Researchers are excited about its potential to provide a more effective and durable response, especially for those with limited treatment options.

What evidence suggests that BMS-663068 might be an effective treatment for HIV?

Research has shown that BMS-663068, which participants in this trial may receive, effectively treats HIV-1 in patients who have tried many other treatments. Studies found that after 48 weeks, 61-82% of people taking BMS-663068 experienced a good response, with reduced virus levels in their blood. Earlier research demonstrated that even after just 8 days of taking BMS-663068, virus levels dropped significantly. This treatment works by preventing the virus from attaching to human cells, thus stopping its spread. Overall, BMS-663068 appears promising for those with difficult-to-treat HIV-1. ^{4 6 7 8 9}

Who Is on the Research Team?

GSK Clinical Trials

Principal Investigator

ViiV Healthcare

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26423650/

Safety and efficacy of the HIV-1 attachment inhibitor ... AI438011 is an ongoing trial investigating the efficacy, safety, and dose-response of BMS-663068 in treatment-experienced, HIV-1-infected patients.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01384734

Study Details | NCT01384734 | HIV Attachment Inhibitor to ... The purpose of this study is to assess the safety, efficacy, tolerability and pharmacokinetics of four doses of BMS-663068 with Raltegravir (RAL) + ...

3. aidsmap.com aidsmap.com/news/mar-2015/hiv-attachment-inhibitor-bms-663068-safe-and-effective-phase-2b-study

HIV attachment inhibitor BMS-663068 safe and effective in ... At 48 weeks, all treatment arms had statistically similar virological response rates, with 61-82% of people taking BMS-663068 and 71% of those ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2352301815001770

Safety and efficacy of the HIV-1 attachment inhibitor ... In the BMS-663068 phase 2a study, 8 days of monotherapy in HIV-1-infected patients resulted in substantial decreases in plasma HIV-1 RNA viral load (1·21–1·73 ...

5. thelancet.com thelancet.com/journals/lanhiv/article/PIIS2352-3018(15)00160-5/abstract

BMS-663068, a safe and effective HIV-1 attachment inhibitor BMS-663068, a safe and effective HIV-1 attachment inhibitor. Ester Ballana ... results of AI438011, a phase 2b, randomised controlled trial. Lancet HIV ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22896665/

Pharmacodynamics, safety, and pharmacokinetics of BMS- ... Administration of BMS-663068 for 8 days with or without ritonavir resulted in substantial declines in plasma HIV-1 RNA levels and was generally well tolerated.

7. caymanchem.com caymanchem.com/product/37708/bms-663068?srsltid=AfmBOoo_zh5-XP2hqStCFGLce7N27MX05VyW7LhC4nrcYqo4vkPoncER

BMS 663068 (Fostemsavir, CAS Number: 864953-29-7) BMS 663068 is a prodrug form of the HIV-1 attachment inhibitor BMS 626529 (Item No. 18413). Formulations containing BMS 663068 have been used in the treatment ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01009814

Study Details | NCT01009814 | Pharmacodynamics, Safety ... The primary assessment of the antiviral activity of BMS-663068 was assessed on the log10 change from Baseline in HIV RNA to Day 9. Baseline was the last non- ...

9. aidsmap.com aidsmap.com/news/mar-2014/hiv-attachment-inhibitor-bms-663068-shows-good-safety-and-efficacy-phase-2b-study

HIV attachment inhibitor BMS-663068 shows good safety ... An early proof-of-concept study showed that eight days of BMS-663068 monotherapy led to HIV viral load reductions of 1.2 to 1.7 log copies/ml.