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 7, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Formic acid
Emtricitabine
Tenofovir
Tenofovir Disoproxil Fumarate
Raltegravir
Raltegravir potassium
U.S. FDA Resources
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00660972
Locations
| United States, California | |
| Ucsd, Avrc 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 Adult AIDS CRS | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Brigham and Women's Hosp. ACTG CRS | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Missouri | |
| Washington U CRS | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| Harlem ACTG CRS | |
| New York, New York, United States, 10037 | |
| AIDS Care 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 | |
| The Ohio State Univ. AIDS CRS | |
| Columbus, Ohio, United States, 43210 | |
| United States, Rhode Island | |
| The Miriam Hosp. ACTG CRS | |
| Providence, Rhode Island, United States, 02906 | |
| United States, Tennessee | |
| Vanderbilt Therapeutics 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:
| 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: | November 7, 2012 |
| 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 June 17, 2013