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

This study has been completed.
Sponsor:
Collaborator:
Adult AIDS Clinical Trials Group
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00660972
First received: April 16, 2008
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention Phase
HIV Infections
Drug: Raltegravir
Drug: Emtricitabine/tenofovir disoproxil fumarate
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: First-Phase Viral Decay Rates in Treatment-Naive Subjects Initiating Treatment With Raltegravir (RAL) and Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF): A Pilot Study

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Viral load decay rates [ Time Frame: Through Day 56 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Viral load decay rates [ Time Frame: From Weeks 24 to 72 ] [ Designated as safety issue: No ]
  • Proportion of participants with a viral load less than 50 copies/ml [ Time Frame: At Weeks 24, 48, and 72 ] [ Designated as safety issue: No ]
  • Safety and tolerability. More information on this criterion can be found in the protocol. [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • CD4 and CD8 count [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Resistance mutations to RAL, FTC, and TDF [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Minimum concentration (Cmin) for RAL, FTC, and TDF [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Changes in viral load [ Time Frame: At Day 7 ] [ Designated as safety issue: No ]
  • Self-reported adherence [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Cell-associated proviral DNA, LTR circular DNA, and integrated proviral DNA [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Viral load [ Time Frame: From Week 24 to Week 72 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: May 2008
Study Completion Date: April 2010
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Oral RAL and FTC/TDF for 72 weeks
Drug: Raltegravir
400 mg tablet taken orally twice daily
Other Name: RAL
Drug: Emtricitabine/tenofovir disoproxil fumarate
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.
Other Name: FTC/TDF

Detailed Description:

Recent data suggests 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 this trial, the viral load decay rate will be estimated in HIV infected, treatment-naive participants receiving RAL and FTC/TDF.

This 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.

This study 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660972

Locations
United States, California
UCSD Antiviral Research Center CRS
San Diego, California, United States, 92103
United States, Colorado
University of Colorado Hospital CRS
Aurora, Colorado, United States, 80045
United States, Illinois
Northwestern University CRS
Chicago, Illinois, United States, 60611
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, Missouri
Washington University Therapeutics (WT) CRS
St. Louis, Missouri, United States, 63110-1010
United States, New York
Harlem ACTG CRS
New York, New York, United States, 10037
Trillium Health ACTG CRS
Rochester, New York, United States, 14607
Univ. of Rochester ACTG CRS
Rochester, New York, United States, 14642
United States, Ohio
MetroHealth CRS
Cleveland, Ohio, United States, 44109
Ohio State University CRS
Columbus, Ohio, United States, 43210
United States, Rhode Island
The Miriam Hospital Clinical Research Site (TMH CRS) CRS
Providence, Rhode Island, United States, 02906
United States, Tennessee
Vanderbilt Therapeutics (VT) CRS
Nashville, Tennessee, United States, 37204
United States, Texas
Houston AIDS Research Team CRS
Houston, Texas, United States, 77030
Sponsors and Collaborators
Adult AIDS Clinical Trials Group
Investigators
Study Chair: Adriana Andrade, MD, MPH Johns Hopkins University
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00660972     History of Changes
Other Study ID Numbers: A5248, 10532, ACTG A5248
Study First Received: April 16, 2008
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

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:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Reverse Transcriptase Inhibitors
Tenofovir
Tenofovir disoproxil
HIV Integrase Inhibitors
Integrase Inhibitors
Emtricitabine
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on July 29, 2014