| ID | Type | Description | Link |
|---|---|---|---|
| P01AI055356 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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The purpose of this study is to determine the safety and effectiveness of an anti-HIV drug regimen followed by treatment interruption in people recently infected with HIV. This study will also compare the effects of a treatment regimen including treatment interruption with a treatment plan based on clinical indicators.
About 6 months after infection, HIV viral load reaches a temporarily stable level known as virus set point. Virus set point is different for each patient and can be a predictor for disease progression. Preliminary studies indicate that early, short-term antiretroviral therapy (ART) given to people newly infected with HIV may lead to lower virus set points and preserved CD4 counts. However, the length of short-term treatment needed to balance the possible adverse effects of ART with the achievement of lower virus set point is not yet known. By lowering the virus set point and maintaining CD4 counts, the need for long-term ART may be postponed. The purpose of this study is to determine the safety and efficacy of a short course of ART on producing a lower virus set point in adults recently infected with HIV.
This study will last at least 28 weeks. Participants will be randomly assigned to one of two arms. Arm A will receive ART for 12 weeks as emtricitabine/tenofovir disoproxil fumarate (TDF/FTC) daily and lopinavir/ritonavir (LPV/RTV) in tablet form twice daily. After 12 weeks, treatment will be interrupted unless the CD4 count is measured to be less than 350 cells/mm^3 on two consecutive occasions during treatment interruption. If that occurs therapy will be resumed. Participants in Arm B will receive no treatment until cluster of differentiation 4 (CD4) counts drop below 350 cells/mm^3, indicating ART is needed. Study visits will occur at study entry, at Weeks 2 and 4, and every 4 weeks thereafter. At each study visit, a physical exam, blood collection, and completion of an adherence questionnaire will occur. Participants are encouraged to enroll in a related substudy that will evaluate HIV viral load in genital secretions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment interruption | Experimental | Oral Tenofovir disoproxil fumarate/Emtricitabine and Lopinavir/Ritonavir for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed. |
|
| CD4 T cell guided therapy | Experimental | Anti Retroviral Therapy initiated when AIDS-defining illness occurs or if CD4 count is confirmed at less than 350 mm^3 at two separate, consecutive measurements |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir disoproxil fumarate/Emtricitabine | Drug | 300 mg Tenofovir disoproxil fumarate/ 200 mg emtricitabine tablet taken orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma HIV-1 Viral Load (Copies/ml) at Week 24 as Compared Between the Two Arms | At Week 24 | |
| Number of Participants Experiencing Either an AIDS-defining Event, a Grade 3 or 4 Adverse Event, or Acute Retroviral Syndrome | At Week 24 | |
| Viral Set Point | set point is reached after the immune system has developed HIV antibodies and begins to attempt to fight the virus | Throughout study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle A. Barron, MD | Division of Infectious Disease, University of Colorado Health Sciences Center | Study Chair |
| Margaret Borok, MRCP | Department of Medicine, University of Zimbabwe | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Health Sciences Center | Denver | Colorado | 80262 | United States | ||
| AIDS Research Consortium of Atlanta |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11148221 | Background | Altfeld M, Rosenberg ES, Shankarappa R, Mukherjee JS, Hecht FM, Eldridge RL, Addo MM, Poon SH, Phillips MN, Robbins GK, Sax PE, Boswell S, Kahn JO, Brander C, Goulder PJ, Levy JA, Mullins JI, Walker BD. Cellular immune responses and viral diversity in individuals treated during acute and early HIV-1 infection. J Exp Med. 2001 Jan 15;193(2):169-80. doi: 10.1084/jem.193.2.169. | |
| 12370504 | Background | Fidler S, Oxenius A, Brady M, Clarke J, Cropley I, Babiker A, Zhang HT, Price D, Phillips R, Weber J. Virological and immunological effects of short-course antiretroviral therapy in primary HIV infection. AIDS. 2002 Oct 18;16(15):2049-54. doi: 10.1097/00002030-200210180-00010. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Interruption | Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed. |
| FG001 | CD4 T Cell Guided Therapy | Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A | Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Plasma HIV-1 Viral Load (Copies/ml) at Week 24 as Compared Between the Two Arms | Posted | Mean | Standard Deviation | Log 10 copies of virus/ml | At Week 24 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A | Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| grade 3 abnormal serum phosphorous level | Metabolism and nutrition disorders | Systematic Assessment | One patient randomized to Arm A experienced a grade 3 abnormal serum phosphorous level at week 4 and 16. The adverse event was not treatment limiting. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| low absolute neutrophil count (ANC) | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle A. Barron | University of Colorado Denver | 303-724-4939 | michelle.barron@ucdenver.edu |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D000068679 | Emtricitabine |
| D061466 | Lopinavir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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|
| Lopinavir/Ritonavir | Drug | Three 400 mg lopinavir/ 100 mg ritonavir soft gel capsules taken orally twice daily |
|
|
| Atlanta |
| Georgia |
| 30308 |
| United States |
| University of Zimbabwe College of Health Sciences | Harare | Zimbabwe |
| 9466517 | Background | Coombs RW, Speck CE, Hughes JP, Lee W, Sampoleo R, Ross SO, Dragavon J, Peterson G, Hooton TM, Collier AC, Corey L, Koutsky L, Krieger JN. Association between culturable human immunodeficiency virus type 1 (HIV-1) in semen and HIV-1 RNA levels in semen and blood: evidence for compartmentalization of HIV-1 between semen and blood. J Infect Dis. 1998 Feb;177(2):320-30. doi: 10.1086/514213. |
| 12466762 | Background | Gallant JE. Current status of antiretroviral treatment interruption and intermittent therapy strategies. MedGenMed. 2002 Sep 19;4(3):19. No abstract available. |
| 11817971 | Background | Gulick RM. Structured treatment interruption in patients infected with HIV: a new approach to therapy. Drugs. 2002;62(2):245-53. doi: 10.2165/00003495-200262020-00001. |
| Arm B |
Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Number of Participants Experiencing Either an AIDS-defining Event, a Grade 3 or 4 Adverse Event, or Acute Retroviral Syndrome | Posted | Number | participants | At Week 24 |
|
|
|
| Primary | Viral Set Point | set point is reached after the immune system has developed HIV antibodies and begins to attempt to fight the virus | Posted | Mean | Standard Deviation | Log 10 copies virus/ml | Throughout study |
|
|
|
| 1 |
| 7 |
| 3 |
| 7 |
| EG001 | Arm B | Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements | 1 | 9 | 5 | 9 |
|
| grade 3 headache | Nervous system disorders | Systematic Assessment | One subject randomized to Arm B experienced a grade 3 headache at baseline. The adverse event was not treatment limiting. |
|
| Elevated aspartate amino transferase | Metabolism and nutrition disorders | Systematic Assessment |
|
| abnormal hemoglobin | Blood and lymphatic system disorders | Systematic Assessment |
|
| abnormal phosphorus | Metabolism and nutrition disorders | Systematic Assessment |
|
| ache/pain/discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| abnormal alanine amino transferase | Metabolism and nutrition disorders | Systematic Assessment |
|
| abnormal glucose | Endocrine disorders | Systematic Assessment |
|
| fatigue/malaise | Metabolism and nutrition disorders | Systematic Assessment |
|
| fever | Infections and infestations | Systematic Assessment |
|
| headache | Nervous system disorders | Systematic Assessment |
|
| abnormal uric acid | Metabolism and nutrition disorders | Systematic Assessment |
|
| congestion/effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| lymphadenopathy | Blood and lymphatic system disorders | Systematic Assessment |
|
| abnormal sodium | Metabolism and nutrition disorders | Systematic Assessment |
|
| blister/ulcer/lesions | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| chills/rigors/sweats/night sweats | Infections and infestations | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| abnormal fasting blood sugar | Endocrine disorders | Systematic Assessment |
|
| macules/papules/rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| mucous membrane/skin abnormality | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| nausea and vomiting/vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| weakness | Blood and lymphatic system disorders | Systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| 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 |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011744 | Pyrimidinones |