Trial Outcomes & Findings for Evaluating the Effect of CHanging EnfuvirtidE to Raltegravir in HIV Infected Subjects (NCT NCT00529243)

Results Overview

To assess the virologic effect of changing enfuvirtide to MK-0518 (raltegravir) in human immunodeficiency virus type 1 (HIV-1) infected patients who have an undetectable level of serum HIV (undetectable level of serum HIV defined as \< 75 copies/ml by bDNA assay or \< 50 copies/ml by Ultrasensitive PCR assay) on their current HIV medication regimen.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

52 participants

Primary outcome timeframe

24 Weeks

Results posted on

2018-08-07

Participant Flow

A multicenter study that enrolled patients from 11 Kaiser Permanente Human Immunodeficiency Virus (HIV) clinics in California. 54 patients were screened. Two patients did not meet protocol inclusion criteria.

Participant milestones

Participant milestones
Measure	MK-0518 (Raltegravir) Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
Overall Study STARTED	52
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	MK-0518 (Raltegravir) Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
Overall Study Adverse Event	1
Overall Study Death	1
Overall Study Relocated	1

Baseline Characteristics

Evaluating the Effect of CHanging EnfuvirtidE to Raltegravir in HIV Infected Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MK-0518 (Raltegravir) n=52 Participants Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
Age, Continuous	53 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants
Region of Enrollment United States	52 participants n=5 Participants
Time of Prior Antiretroviral Therapy Use	15 years n=5 Participants
Number of Past Antiretrovials Used	15 medications n=5 Participants
Time on Enfuvirtide Therapy	997 days n=5 Participants

PRIMARY outcome

Timeframe: 24 Weeks

Population: Analysis used the intent to treat (ITT) population, defined as all patients who received at least one dose of raltegravir.

To assess the virologic effect of changing enfuvirtide to MK-0518 (raltegravir) in human immunodeficiency virus type 1 (HIV-1) infected patients who have an undetectable level of serum HIV (undetectable level of serum HIV defined as \< 75 copies/ml by bDNA assay or \< 50 copies/ml by Ultrasensitive PCR assay) on their current HIV medication regimen.

Outcome measures

Outcome measures
Measure	MK-0518 (Raltegravir) n=52 Participants Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
Number of Patients With Undetectable Human Immunodeficiency Virus (HIV) Viral Load at Week 24.	49 participants

SECONDARY outcome

Timeframe: 24 Weeks

Population: Analysis was per intention to treat (ITT) population defined as all patients who received at least one dose of raltegravir.

To study the immunologic effect of changing enfuvirtide to MK-0518 (raltegravir) in HIV-1 infected patients who have an undetectable level of serum HIV (undetectable serum HIV defined as \< 75 copies/ml by bDNA assay or \< 50 copies/ml by Ultrasensitive PCR assay)on their current HIV medication regimen.

Outcome measures

Outcome measures
Measure	MK-0518 (Raltegravir) n=52 Participants Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
Average Change in Cluster of Differentiation 4(CD4) Cell Count From Baseline at Week 24	32 cells/mm^3 Interval -165.0 to 1362.0

Adverse Events

MK-0518 (Raltegravir)

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MK-0518 (Raltegravir) n=52 participants at risk Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
Blood and lymphatic system disorders Septicemia	1.9% 1/52 • Number of events 1 • 33 Weeks Any adverse event (i.e., a new event or an exacerbation of a pre-existing condition) with an onset date after study drug administration up to the last day on study (including the follow-up, off study medication period of the study), should be recorded.
Endocrine disorders Diabetic Ketoacidosis	1.9% 1/52 • Number of events 1 • 33 Weeks Any adverse event (i.e., a new event or an exacerbation of a pre-existing condition) with an onset date after study drug administration up to the last day on study (including the follow-up, off study medication period of the study), should be recorded.
Gastrointestinal disorders Death	1.9% 1/52 • Number of events 1 • 33 Weeks Any adverse event (i.e., a new event or an exacerbation of a pre-existing condition) with an onset date after study drug administration up to the last day on study (including the follow-up, off study medication period of the study), should be recorded.

Other adverse events

Other adverse events
Measure	MK-0518 (Raltegravir) n=52 participants at risk Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
Nervous system disorders Fatigue	5.8% 3/52 • Number of events 3 • 33 Weeks Any adverse event (i.e., a new event or an exacerbation of a pre-existing condition) with an onset date after study drug administration up to the last day on study (including the follow-up, off study medication period of the study), should be recorded.
Hepatobiliary disorders alanine aminotransferase (ALT)	11.5% 6/52 • Number of events 6 • 33 Weeks Any adverse event (i.e., a new event or an exacerbation of a pre-existing condition) with an onset date after study drug administration up to the last day on study (including the follow-up, off study medication period of the study), should be recorded.
Renal and urinary disorders serum creatinine elevation	5.8% 3/52 • Number of events 3 • 33 Weeks Any adverse event (i.e., a new event or an exacerbation of a pre-existing condition) with an onset date after study drug administration up to the last day on study (including the follow-up, off study medication period of the study), should be recorded.

Additional Information

William Towner, MD

Kaiser Permanente

Phone: 323-783-7855

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place