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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: November 4, 2014
Last verified: November 2014

April 16, 2008
November 4, 2014
May 2008
January 2009   (final data collection date for primary outcome measure)
Viral load decay rates [ Time Frame: Through Day 56 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00660972 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of Viral Load Decay Rates in HIV Infected Participants Starting Treatment With Raltegravir (RAL) and Emtricitabine/Tenofovir Disoproxil Fumarate (TDF)
First-Phase Viral Decay Rates in Treatment-Naive Subjects Initiating Treatment With Raltegravir (RAL) and Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF): A Pilot Study

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).

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.

Interventional
Phase 1
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • 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
Experimental: 1
Oral RAL and FTC/TDF for 72 weeks
Interventions:
  • Drug: Raltegravir
  • Drug: Emtricitabine/tenofovir disoproxil fumarate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
April 2010
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00660972
A5248, 10532, ACTG A5248
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Adult AIDS Clinical Trials Group
Study Chair: Adriana Andrade, MD, MPH Johns Hopkins University
National Institute of Allergy and Infectious Diseases (NIAID)
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP