Intensive Viral Dynamics Substudy of A5248

October 28, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Colorado
  - Aurora, Colorado, United States, 80045
    - University of Colorado Hospital CRS
- Maryland
  - Baltimore, Maryland, United States, 21205
    - Johns Hopkins University CRS
  - Baltimore, Maryland, United States, 21201
    - IHV Baltimore Treatment CRS
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS
- New York
  - Rochester, New York, United States, 14607
    - Trillium Health ACTG CRS
- Tennessee
  - Nashville, Tennessee, United States, 37204
    - Vanderbilt Therapeutics (VT) CRS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

HIV-infected participants currently enrolled in study A5248

Description

Inclusion Criteria:

Enrollment in A5248
Willing and able to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time at which first-phase viral decay begins Time Frame: Throughout study	Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair: Adriana Andrade, MD, MPH, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

February 26, 2009

First Submitted That Met QC Criteria