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Intensive Viral Dynamics Substudy of A5248

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00852618
Recruitment Status : Completed
First Posted : February 27, 2009
Last Update Posted : June 10, 2015
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:

The HIV integrase inhibitor, raltegravir (RAL), which was recently approved by the FDA, has been shown in several trials to be highly effective. The main study will estimate the viral load decay rate in treatment-naive HIV-infected participants receiving RAL and emtricitabine/tenofovir disoproxil fumarate (FTC/TDF).

This substudy of A5248 will similarly examine the characteristics of decrease in viral load but will focus on estimating the time at which first-phase viral decay starts, following initiation of the study drugs.

Condition or disease
HIV Infections Treatment Naive

Detailed Description:

Recent data suggest that early virologic response to HIV interventions may be predictive of long-term virologic outcomes. Defining early decay in viral load through carefully performed studies of viral dynamics may be a useful tool for assessing the likely outcome of long-term treatment. It may also be a useful screening tool to define which combinations should be studied further. In the main study, the viral load decay rate will be estimated in HIV-infected, treatment-naive participants receiving RAL and FTC/TDF.

The A5248 study will last approximately 72 weeks. All participants will take RAL and FTC/TDF for 72 weeks. RAL will be provided by the study. FTC/TDF will not be provided.

A5248 will consist of 16 study visits. These visits will occur at study entry; Days 2, 7, 10, 14, 21, 28, and 56, and Weeks 12, 16, 20, 24, 36, 48, 60, and 72. Blood collection and pharmacokinetic studies will occur at all study visits. Self-reported adherence assessments will be submitted at each visit. A targeted physical exam will occur at most visits. Liver function tests and urine collection will occur at select visits. Pregnancy tests will occur whenever pregnancy is suspected.

This substudy will enroll 10 participants from A5248. It is critical that substudy participants take their medications as directed to ensure accurate trial results. Any participant who discontinues study treatment will also be removed from the substudy and replaced. Participants will be asked about medication holds and adherence.

No medications will be provided by the substudy. Study treatment will be provided and administered as per the main study, A5248. After participants begin study medications, samples will be collected for the substudy. Participants will be required to stay overnight and in the hospital from Day 0 until Day 2. The morning study medication dose will be administered in the clinic on Days, 2, 3, 4, and 7.

Medication diaries will be provided for participants on Day 2. Participants will be instructed to record the times they take their study medications through Day 7 of the study. Participants are required to bring these diaries to their study visits on Days 3, 4, and 7 for review.

Participants may discontinue their enrollment in this substudy and still remain in the main study, A5248. Participants may not discontinue their involvement in A5248 and remain in the substudy.

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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Intensive Viral Dynamics Substudy of A5248
Study Start Date : May 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Participants undergoing treatment with raltegravir (RAL) in the main study
Participants undergoing treatment with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in the main study

Primary Outcome Measures :
  1. Time at which first-phase viral decay begins [ Time Frame: Throughout study ]

Biospecimen Retention:   Samples Without DNA
Plasma samples will be collected throughout the study

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV-infected participants currently enrolled in study A5248

Inclusion Criteria:

  • Enrollment in A5248
  • Willing and able to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00852618

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United States, Colorado
University of Colorado Hospital CRS
Aurora, Colorado, United States, 80045
United States, Maryland
IHV Baltimore Treatment CRS
Baltimore, Maryland, United States, 21201
Johns Hopkins University CRS
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS
Boston, Massachusetts, United States, 02115
United States, New York
Trillium Health ACTG CRS
Rochester, New York, United States, 14607
United States, Tennessee
Vanderbilt Therapeutics (VT) CRS
Nashville, Tennessee, United States, 37204
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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Study Chair: Adriana Andrade, MD, MPH Johns Hopkins University

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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00852618    
Other Study ID Numbers: A5249s
10618 ( Registry Identifier: DAIDS ES )
First Posted: February 27, 2009    Key Record Dates
Last Update Posted: June 10, 2015
Last Verified: June 2015
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Integrase Inhibitors
HIV Nucleoside Reverse Transcriptase Inhibitors
Treatment Naive
Viral Load
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases