Trial Outcomes & Findings for Pilot Study of Adding Raltegravir (MK-0518) to Antiretroviral Therapy in Patients With Low Level Viremia (NCT NCT00618371)

Results Overview

HIV RNA levels were determined with a non-commercial, sensitive single copy assay for HIV. The primary outcome measure was to determine the number of individuals with ≥10fold decrease in HIV RNA

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

4 weeks

Results posted on

2017-02-01

Participant Flow

The study was approved in 10/2007. HIV-infected individuals 18 years of age receiving stable, suppressive antiretroviral therapy (ART) with persistent plasma HIV-1 RNA level of \> 0.6 copies/mL by single-copy assay at screening; enrollment started in in 12/2007 at the University of Pittsburgh Clinical Trials Unit from 12/2007 through 1/2009.

Participants had Cluster of Differentiation 4(CD4) counts of greater than 200 cells/microliter, HIVRNA\< 50 copies/mL plasma for ≥12 months; and not receiving prophylaxis for opportunistic infections (OI)s; no history of exposure to raltegravir, HIV-1 drug resistance,febrile illness within 3 weeks or vaccination within 6 weeks before enrollment.

Participant milestones

Participant milestones
Measure	Group 1 group to be treated with raltegravir
Overall Study STARTED	12
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 group to be treated with raltegravir
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Pilot Study of Adding Raltegravir (MK-0518) to Antiretroviral Therapy in Patients With Low Level Viremia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=12 Participants Group receiving raltegravir
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	45.5 years STANDARD_DEVIATION 10.6 • n=5 Participants
Gender Female	1 Participants n=5 Participants
Gender Male	11 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Number of participants based on estimates of how many will have decreased viral RNA levels. If 10 participants do not have decreased RNA, the number of patients with potential for decrease is \<15% of all suppressed patients.

HIV RNA levels were determined with a non-commercial, sensitive single copy assay for HIV. The primary outcome measure was to determine the number of individuals with ≥10fold decrease in HIV RNA

Outcome measures

Outcome measures
Measure	Raltegravir Intensification n=10 Participants participants received 4 wk raltegravir intensification
Number of Participants With HIV-1 RNA Response: ≥ 1 Log Decrease in Viral Load	0 participants

SECONDARY outcome

Timeframe: 4 weeks

Population: 0 participants were analyzed because no patients had ≥10 fold decrease in viral RNA. As described in patient outcome description, we would sequence patients only if a ≥10- fold decrease in viremia occurred, Since no one experienced ≥10 fold decrease in viremia, no sequencing could be performed.

We planned to compare HIV DNA levels and HIV genetic variation in individuals with and without ≥10 fold decreases in HIV RNA. As none of the patients had a decline in viral RNA, this analysis could not be readily analyzed

Outcome measures

Outcome data not reported

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Deborah McMahon

University of Pittsburgh

Phone: 412-383-1675

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place