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

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ClinicalTrials.gov Identifier: NCT00618371
Recruitment Status : Completed
First Posted : February 20, 2008
Results First Posted : December 6, 2016
Last Update Posted : February 1, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Frank Maldarelli, National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition HIV Infection
Intervention Drug: Raltegravir (MK-0518)
Enrollment 10
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Group 1
Hide Arm/Group Description group to be treated with raltegravir
Period Title: Overall Study
Started 12
Completed 10
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Arm/Group Title Group 1
Hide Arm/Group Description Group receiving raltegravir
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
  91.7%
>=65 years
1
   8.3%
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
45.5  (10.6)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
1
   8.3%
Male
11
  91.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Number of Participants With HIV-1 RNA Response: ≥ 1 Log Decrease in Viral Load
Hide Description 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
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Raltegravir Intensification
Hide Arm/Group Description:
participants received 4 wk raltegravir intensification
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
0
2.Secondary Outcome
Title Proviral DNA Response, HIV-1 Sequence Variation Levels of Cell Associated HIV DNA and Genetic Variation in HIV During Raltegravir Addition in Individuals Who Have Declines in HIV
Hide Description 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
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Raltegravir Intensification
Hide Arm/Group Description:
participants received 4 wk raltegravir intensification. Samples from 0 participants were analyzed No Patients experienced ≥ 1 log decline in viral RNA, so no samples could be analyzed
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame entire trial period of 18 months and thought the end of study period directly after 18 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1
Hide Arm/Group Description group treated with raltegravir
All-Cause Mortality
Group 1
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1
Affected / at Risk (%)
Total   0/10 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Deborah McMahon
Organization: University of Pittsburgh
Phone: 412-383-1675
Publications:
Responsible Party: Frank Maldarelli, National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00618371     History of Changes
Other Study ID Numbers: 27XS050
HHSN261200800001E ( Other Grant/Funding Number: SAIC )
ZIABC011464 ( U.S. NIH Grant/Contract )
First Submitted: September 29, 2007
First Posted: February 20, 2008
Results First Submitted: September 12, 2011
Results First Posted: December 6, 2016
Last Update Posted: February 1, 2017