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Attachment Inhibitor

BMS-663068 for HIV

Phase 3

Waitlist Available

Research Sponsored by ViiV Healthcare

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Failing current antiretroviral regimen with a confirmed plasma HIV-1 RNA ≥ 400 c/mL (first value from Investigator, second from Screening labs)

Able to receive ≥ 1 fully active approved antiretroviral as part of the OBT from Day 9 onwards in the Randomized Cohort

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and at day 8, weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84 and 96

Awards & highlights

Study Summary

This trial will test whether a new drug is effective in treating HIV-1 patients who have developed resistance to multiple drugs.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects of BMS-663068 are not listed here, similar medications often cause issues like nausea, headaches, fatigue, and possible allergic reactions. The severity can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am living with chronic HIV-1 and am not pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and at day 8, weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84 and 96

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and at day 8, weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84 and 96

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at day 8, weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84 and 96 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean Change in Logarithm to the Base 10 (log10) HIV-1 Ribonucleic Acid (RNA) From Day 1 at Day 8-Randomized Cohort

Secondary outcome measures

Change From Baseline in CD4+ T- Cell Count Percentage Through Week 96

Change From Baseline in CD4+ T- Cell Count Through Week 96-Randomized Cohort

Change From Baseline in log10 HIV-1 RNA for Fostemsavir When Given With OBT Through Week 96-Randomized Cohort

+10 more

Side effects data

From 2010 Phase 2 trial • 50 Patients • NCT01009814

30%

HEADACHE

10%

INFLUENZA LIKE ILLNESS

10%

NEURALGIA

10%

MICTURITION URGENCY

10%

RASH

10%

DISCOMFORT

100%

80%

60%

40%

20%

Study treatment Arm

BMS-663068 1200 mg QHS + RTV 100 mg QHS

BMS-663068 600 mg Q12H + RTV 100 mg Q12H

BMS-663068 1200 mg Q12H + RTV 100 mg Q12H

BMS-663068 1200 mg Q12H + RTV 100 mg QAM

BMS-663068 1200 mg Q12H

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: BMS-663068Experimental Treatment1 Intervention

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

Group II: A1: BMS-663068Experimental Treatment1 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-663068Active Control2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BMS-663068

2014

Completed Phase 2

~680

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

ViiV HealthcareLead Sponsor

359 Previous Clinical Trials

468,172 Total Patients Enrolled

GSK Clinical TrialsStudy DirectorViiV Healthcare

3,595 Previous Clinical Trials

6,143,559 Total Patients Enrolled

Media Library

Human Immunodeficiency Virus Infection Research Study Groups: A1: BMS-663068, B1: Placebo + BMS-663068, BMS-663068

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the BMS-663068 drug's FDA classification?

"BMS-663068 was given a safety score of 3 because there is already some data supporting its efficacy and multiple rounds of data that suggest it is safe."

Answered by AI

What is BMS-663068 used to treat most frequently?

"BMS-663068 can help people who have human immunodeficiency virus type 1 (hiv-1) infection, have experience with anti-retroviral agents, and are currently undergoing antiretroviral treatment."

Answered by AI

Is this research project new and original?

"BMS-663068 has 2 ongoing studies in 61 cities and 25 countries. ViiV Healthcare sponsored the initial trial in 2015, which involved 371 patients and completed Phase 3 drug approval. Since then, 18283 trials have been completed."

Answered by AI

What other scientific research has been done on BMS-663068?

"BMS-663068 was first studied in 2015 at the GSK Investigational Site. There have been a total of 18283 completed trials since then. There are currently 2 active trials, with many of these studies taking place in Tulsa, Oklahoma."

Answered by AI