Study of Viral Load Decay Rates in HIV Infected Participants Starting Treatment With Raltegravir (RAL) and Emtricitabine/Tenofovir Disoproxil Fumarate (TDF)

NCT00660972 | Completed Phase 1

• 3 other identifiers: A524810532ACTG A5248
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 15

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 purpose of this trial is to estimate the viral load decay rate in treatment-naive HIV infected participants receiving RAL and emtricitabine/tenofovir disoproxil fumarate (FTC/TDF).

Conditions

HIV Infections

Keywords

HIV Integrase Inhibitors; HIV Nucleoside Reverse Transcriptase Inhibitors; Treatment Naive; Viral Load

Outcome Measures

Primary Outcomes (1)

• Viral load decay rates

  Through Day 56

Secondary Outcomes (10)

• Viral load decay rates

  From Weeks 24 to 72

• Proportion of participants with a viral load less than 50 copies/ml

  At Weeks 24, 48, and 72

• Safety and tolerability. More information on this criterion can be found in the protocol.

  Throughout study

• CD4 and CD8 count

  Throughout study

• Resistance mutations to RAL, FTC, and TDF

  Throughout study

Study Arms (1)

1

EXPERIMENTAL

Oral RAL and FTC/TDF for 72 weeks

Drug: Raltegravir; Drug: Emtricitabine/tenofovir disoproxil fumarate

Interventions

Raltegravir DRUG

400 mg tablet taken orally twice daily

Also known as: RAL

1

Emtricitabine/tenofovir disoproxil fumarate DRUG

Fixed dose tablet containing 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate taken once daily. FTC/TDF will not be provided by the study and must be obtained by the particpant's health care provider.

Also known as: FTC/TDF

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV infected
• Antiretroviral treatment naive
• Viral load at least 10,000 and less than 300,000 copies/ml within 42 days prior to study entry
• Agree to use appropriate form of contraception. More information on this criterion can be found in the protocol.

You may not qualify if:

• Received HIV-specific immunizations within 6 months prior to study entry
• Received immunizations within 6 months prior to study entry
• Known allergy or sensitivity to study drugs
• Any participant with an acute AIDS-defining opportunistic infection (OI) who is not clinically stable or who has not been on therapy for the OI for at least 30 days prior to study entry
• Treatment with immune modulators or any investigational therapy within 30 days prior to study entry
• Evidence of HIV seroconversion within 6 months prior to study entry
• Illness requiring systemic treatment and/or hospitalization
• Substance abuse that, in the opinion of the investigator, would interfere with adherence to study requirements
• Requirement for any current medications that are prohibited with any study medication. More information on this criterion can be found in the protocol.
• Evidence of any major resistance-associated mutation on any genotype performed prior to study entry or at the time of screening. More information on this criterion can be found in the protocol.
• Abnormal laboratory values. More information on this criterion can be found in the protocol.
• Pregnant or breastfeeding

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Adult AIDS Clinical Trials Group: collaborator

Study Sites (15)

UCSD Antiviral Research Center CRS

San Diego, California, 92103, United States

Location

University of Colorado Hospital CRS

Aurora, Colorado, 80045, United States

Location

Northwestern University CRS

Chicago, Illinois, 60611, 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

Washington University Therapeutics (WT) CRS

St Louis, Missouri, 63110-1010, United States

Location

Harlem ACTG CRS

New York, New York, 10037, United States

Location

Trillium Health ACTG CRS

Rochester, New York, 14607, United States

Location

Univ. of Rochester ACTG CRS

Rochester, New York, 14642, United States

Location

MetroHealth CRS

Cleveland, Ohio, 44109, United States

Location

Ohio State University CRS

Columbus, Ohio, 43210, United States

Location

The Miriam Hospital Clinical Research Site (TMH CRS) CRS

Providence, Rhode Island, 02906, United States

Location

Vanderbilt Therapeutics (VT) CRS

Nashville, Tennessee, 37204, United States

Location

Houston AIDS Research Team CRS

Houston, Texas, 77030, United States

Location

Related Publications (4)

• Evering TH, Markowitz M. Raltegravir: an integrase inhibitor for HIV-1. Expert Opin Investig Drugs. 2008 Mar;17(3):413-22. doi: 10.1517/13543784.17.3.413.

  PMID: 18321239 BACKGROUND

• Sedaghat AR, Dinoso JB, Shen L, Wilke CO, Siliciano RF. Decay dynamics of HIV-1 depend on the inhibited stages of the viral life cycle. Proc Natl Acad Sci U S A. 2008 Mar 25;105(12):4832-7. doi: 10.1073/pnas.0711372105. Epub 2008 Mar 24.

  PMID: 18362342 BACKGROUND

• Funderburg NT, Xu D, Playford MP, Joshi AA, Andrade A, Kuritzkes DR, Lederman MM, Mehta NN. Treatment of HIV infection with a raltegravir-based regimen increases LDL levels, but improves HDL cholesterol efflux capacity. Antivir Ther. 2017;22(1):71-75. doi: 10.3851/IMP3091. Epub 2016 Oct 14.

  PMID: 27740536 DERIVED

• Funderburg NT, Andrade A, Chan ES, Rosenkranz SL, Lu D, Clagett B, Pilch-Cooper HA, Rodriguez B, Feinberg J, Daar E, Mellors J, Kuritzkes D, Jacobson JM, Lederman MM. Dynamics of immune reconstitution and activation markers in HIV+ treatment-naive patients treated with raltegravir, tenofovir disoproxil fumarate and emtricitabine. PLoS One. 2013 Dec 18;8(12):e83514. doi: 10.1371/journal.pone.0083514. eCollection 2013.

  PMID: 24367599 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Adriana Andrade, MD, MPH

  Johns Hopkins University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2008
• First Posted: April 18, 2008
• Study Start: May 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: April 1, 2010
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

US (15)