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| ID | Type | Description | Link |
|---|---|---|---|
| 10532 | Registry Identifier | DAIDS ES | |
| ACTG A5248 |
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| Name | Class |
|---|---|
| Adult AIDS Clinical Trials Group | NETWORK |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Oral RAL and FTC/TDF for 72 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raltegravir | Drug | 400 mg tablet taken orally twice daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Viral load decay rates | Through Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adriana Andrade, MD, MPH | Johns Hopkins University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Antiviral Research Center CRS | San Diego | California | 92103 | United States | ||
| University of Colorado Hospital CRS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18321239 | Background | 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. | |
| 18362342 | 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. |
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| 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. |
|
|
| Throughout study |
| CD4 and CD8 count | Throughout study |
| Resistance mutations to RAL, FTC, and TDF | Throughout study |
| Minimum concentration (Cmin) for RAL, FTC, and TDF | Throughout study |
| Changes in viral load | At Day 7 |
| Self-reported adherence | Throughout study |
| Cell-associated proviral DNA, LTR circular DNA, and integrated proviral DNA | Throughout study |
| Viral load | From Week 24 to Week 72 |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Northwestern University CRS | Chicago | Illinois | 60611 | United States |
| IHV Baltimore Treatment CRS | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins University CRS | Baltimore | Maryland | 21205 | United States |
| Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS | Boston | Massachusetts | 02115 | United States |
| Washington University Therapeutics (WT) CRS | St Louis | Missouri | 63110-1010 | United States |
| Harlem ACTG CRS | New York | New York | 10037 | United States |
| Trillium Health ACTG CRS | Rochester | New York | 14607 | United States |
| Univ. of Rochester ACTG CRS | Rochester | New York | 14642 | United States |
| MetroHealth CRS | Cleveland | Ohio | 44109 | United States |
| Ohio State University CRS | Columbus | Ohio | 43210 | United States |
| The Miriam Hospital Clinical Research Site (TMH CRS) CRS | Providence | Rhode Island | 02906 | United States |
| Vanderbilt Therapeutics (VT) CRS | Nashville | Tennessee | 37204 | United States |
| Houston AIDS Research Team CRS | Houston | Texas | 77030 | United States |
| 27740536 | Derived | 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. |
| 24367599 | 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. |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068898 | Raltegravir Potassium |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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