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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
Must not have
Chronic untreated Hepatitis B virus (HBV) (however, patients with chronic treated HBV are eligible)
HIV-2 infection
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
Pivotal Trial

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.
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.
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.
Select...
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have chronic Hepatitis B but am receiving treatment for it.
Select...
I am infected with HIV-2.

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
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Change in Logarithm to the Base 10 (log10) HIV-1 Ribonucleic Acid (RNA) From Day 1 at Day 8-Randomized Cohort
Secondary study objectives
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%
RASH
10%
MICTURITION URGENCY
10%
NEURALGIA
10%
INFLUENZA LIKE ILLNESS
10%
DISCOMFORT
100%
80%
60%
40%
20%
0%
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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Find a Location

Who is running the clinical trial?

ViiV HealthcareLead Sponsor
375 Previous Clinical Trials
470,411 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorViiV Healthcare
3,608 Previous Clinical Trials
6,145,093 Total Patients Enrolled

Media Library

Human Immunodeficiency Virus Infection Research Study Groups: A1: BMS-663068, B1: Placebo + BMS-663068, BMS-663068
~35 spots leftby Dec 2025
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