NCT00852618

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2008

Shorter than P25 for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 27, 2009

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

First QC Date

February 26, 2009

Last Update Submit

October 28, 2021

Conditions

HIV InfectionsTreatment Naive

Keywords

HIV Integrase InhibitorsHIV Nucleoside Reverse Transcriptase InhibitorsTreatment NaiveViral Load

Outcome Measures

Primary Outcomes (1)

  • Time at which first-phase viral decay begins

    Throughout study

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HIV-infected participants currently enrolled in study A5248

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Colorado Hospital CRS

Aurora, Colorado, 80045, United States

Location

IHV Baltimore Treatment CRS

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins University CRS

Baltimore, Maryland, 21205, United States

Location

Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS

Boston, Massachusetts, 02115, United States

Location

Trillium Health ACTG CRS

Rochester, New York, 14607, United States

Location

Vanderbilt Therapeutics (VT) CRS

Nashville, Tennessee, 37204, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples will be collected throughout the study

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Adriana Andrade, MD, MPH

    Johns Hopkins University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2009

First Posted

February 27, 2009

Study Start

May 1, 2008

Study Completion

September 1, 2008

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations

US(6)