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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA032106 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Asociación Civil Impacta Salud y Educación, Peru | OTHER |
| Asociación Civil Via Libre, Peru | OTHER |
| Epicentro, Peru | UNKNOWN |
| National Institute on Drug Abuse (NIDA) |
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This study will recruit men and transgender women with acute or recent HIV infection. It wil look at how HIV medicines (ART) when given very early after HIV infection affect the amount of HIV in the blood, semen and rectal secretions. In addition, Investigators will be using modeling studies to look at whether or not this kind of HIV treatment can decrease the risk that a man will infect a person he has sex with and to find out how failure to take medications will impact spreading the virus to other people.
In this study, one group will be randomized (like a coin toss) to start ART immediately (just at the time of the enrollment visit) and the other group will wait until week 24 of the study to start ART. Both groups will be followed for a total of 48 weeks and will continue to receive ART from local sources after the study is over.
This is three-step study. Step 1 will screen men who have sex with men (MSM) and transgender women who are unaware of their HIV status and 1) report high risk behaviors for acquiring HIV-1 infection or 2) who have symptoms of acute retroviral syndrome or 3) who have a sexual partner with newly-diagnosed acute or recent HIV infection. HIV testing will be conducted for several thousand MSM and transgender women from study opening until July 2015. In Step 2, high risk HIV-1 uninfected MSM and transgender women with high risk for acquiring HIV will be tested at regular intervals for incident HIV-1 (using tests for HIV p24 and/or HIV RNA). (During this period, men will receive standard HIV prevention interventions.) In Step 3, individuals with acute or recent HIV-1 infection will be enrolled in a 48-week randomized, open-label study of the effects of immediate vs. deferred ART on the decay dynamics of HIV viral load in plasma, semen and rectal secretions. (ART will be provided prior to 24 weeks for any participant in the deferred ART arm who meets initiation criteria.) All participants will be followed for 48 weeks after which they will continue ART from other sources.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate ART (Atripla or Stribild) | Active Comparator | Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at enrollment. |
|
| Deferred ART (Atripla or Stribild) | Placebo Comparator | Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atripla or Stribild | Drug | Antiretroviral therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With HIV Viral Load Suppression in Plasma | To quantify HIV viral load suppression (<1000 copies/mL) in plasma at Baseline and weeks 12, 24, 36, and 48 weeks Suppressed at Baseline = HIV Viral load measured at the time of enrollment was <1000 copies/mL Suppressed at Week 12 = HIV Viral load measured 12 weeks after enrollment was <1000 copies/mL etc. | Baseline, Week 12, Week 24, Week 36, and Week 48 |
| Number of Participants With HIV Viral Load Suppression in Semen | To quantify HIV viral load suppression (<1000 copies/mL) in semen at Baseline and weeks 12, and, 24 weeks | Baseline, Week 12, and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | HIV present in blood samples from recently infected study participants was sequenced. Sequences that were similar to each other were grouped together in clusters. For this analysis, clusters were defined using a patristic distance threshold of 0.01, and a minimum cluster size of two. | HIV diagnosis visit |
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Inclusion Criteria:
Exclusion Criteria:
Prior receipt of investigational anti-HIV vaccine
Ongoing therapy with any of the following:
Known allergy/sensitivity or any hypersensitivity to components of study drugs (ART) or their formulations
Active drug or alcohol use or dependence that would interfere with adherence to study requirements
Serious medical or psychiatric illness that would interfere with the ability to adhere to study requirements
Chronic or acute hepatitis B infection
Use of female hormonal products based on estrogen or derivatives
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| Name | Affiliation | Role |
|---|---|---|
| Ann Duerr, M.D. | Fred Hutchinson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asociación Civil Impacta Salud y Educación | Lima | Peru |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34702087 | Derived | Bachman VF, Montano MA, Ulrich A, Villaran M, Cabello R, Gonzalez P, Sanchez H, Lama JR, Duerr A. Correlates of condomless anal intercourse with different types of sexual partners among men who have sex with men and transgender women in Lima, Peru. AIDS Care. 2023 Jun;35(6):791-799. doi: 10.1080/09540121.2021.1994517. Epub 2021 Oct 26. | |
| 33148993 | Derived | Mayer ME, White E, Montano MA, Lama JR, Sanchez H, Cabello R, Sanchez J, Pasalar S, Duerr A. Sexual Behavior Among Men Who Have Sex With Men: The Need for More Targeted Outreach to Men Who Also Have Sex With Cisgender Women. J Acquir Immune Defic Syndr. 2021 Mar 1;86(3):265-270. doi: 10.1097/QAI.0000000000002568. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate ART (Atripla or Stribild) | Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at enrollment. Atripla or Stribild: Antiretroviral therapy |
| FG001 | Deferred ART (Atripla or Stribild) | Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at 24 weeks. Atripla or Stribild: Antiretroviral therapy |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
5 participants from the Immediate arm and 4 participants from the Deferred arm were excluded from the analyses because by the time they were enrolled they could no longer be considered Acute or Recent HIV infection.
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate ART (Atripla or Stribild) | Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at enrollment. Atripla or Stribild: Antiretroviral therapy |
| BG001 | Deferred ART (Atripla or Stribild) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With HIV Viral Load Suppression in Plasma | To quantify HIV viral load suppression (<1000 copies/mL) in plasma at Baseline and weeks 12, 24, 36, and 48 weeks Suppressed at Baseline = HIV Viral load measured at the time of enrollment was <1000 copies/mL Suppressed at Week 12 = HIV Viral load measured 12 weeks after enrollment was <1000 copies/mL etc. | Not all participants had their viral load measured at all time points due to a missed visit or being lost to follow up. | Posted | Count of Participants | Participants | Baseline, Week 12, Week 24, Week 36, and Week 48 |
|
48 weeks
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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 | Immediate ART (Atripla or Stribild) | Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at enrollment. Atripla or Stribild: Antiretroviral therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transaminases increased | Investigations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Proctitis chlamydial | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ann Duerr | Fred Hutchinson Cancer Center | 206 667 7938 | aduerr@fredhutch.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 10, 2019 | Aug 8, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000068257 | Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| D000069545 | Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| NIH |
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| Percent of Participants Whose HIV Sequences Appear in Phylogenetically Defined Clusters | HIV present in blood samples from recently infected study participants was sequenced. Sequences that were similar to each other were grouped together in clusters. For this analysis, clusters were defined using a patristic distance threshold of 0.01, and a minimum cluster size of two. | HIV diagnosis visit |
| Number of Participants Diagnosed With Acute HIV Infection Who Were Linked to Care | To determine the proportion of individuals with evidence of acute infection (HIV-1 RNA-positive) who are successfully contacted for confirmatory HIV testing and are then linked to care. | within 3 months of diagnosis of acute HIV infection |
| Partner Tracing | Partner tracing and notification | within 3 months of diagnosis |
| Number of Participants Retained in Care | To determine the number of participants who were retained in care at weeks 12, 24, 36, and 48 | Baseline, Week 12, Week 24, Week 36, and Week 48 |
| Adherence to ART Regimen (Percentage of Pills Taken) | To determine percentage of ART pills taken by participants randomized to immediate and deferred ART initiation. | 48 weeks |
| Adherence to Viral Load (VL) Procedure | To determine the number of participants who had a viral load test at Baseline and weeks 12, 24, 36, and 48 | Baseline, Week 12, Week 24, Week 36, and Week 48 |
| Adherence to CD4 Procedure | To determine the number of participants who had a CD4 test at Baseline and weeks 12, 24, 36, and 48 | Baseline, Week 12, Week 24, Week 36, and Week 48 |
| Adherence to Questionnaires | To determine the number of participants who completed the Computer Assisted Self interviews (CASI) at Baseline and weeks 12, 24, 36, and 48 | Baseline, Week 12, Week 24, Week 36, and Week 48 |
| 32107526 | Derived | Lama JR, Ignacio RAB, Alfaro R, Rios J, Cartagena JG, Valdez R, Bain C, Barbaran KS, Villaran MV, Pilcher CD, Gonzales P, Sanchez J, Duerr A. Clinical and Immunologic Outcomes After Immediate or Deferred Antiretroviral Therapy Initiation During Primary Human Immunodeficiency Virus Infection: The Sabes Randomized Clinical Study. Clin Infect Dis. 2021 Mar 15;72(6):1042-1050. doi: 10.1093/cid/ciaa167. |
| Excluded from analysis |
|
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at 24 weeks. Atripla or Stribild: Antiretroviral therapy |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline Viral Load | This is a measure of the amount of HIV virus in the blood at the time of enrollment (Baseline). | Mean | Standard Deviation | Log10(copies/mL) |
|
| Baseline CD4 | This is a measure of CD4 white blood cells in the blood at the time of enrollment (Baseline). A lower CD4 could indicate a more compromised immune system. | 2 participants in the Immediate arm and 1 participant in the deferred arm are missing a baseline CD4. | Mean | Standard Deviation | CD4 T Cell count/mm^3 |
|
| OG001 |
| Deferred ART (Atripla or Stribild) |
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at 24 weeks. Atripla or Stribild: Antiretroviral therapy |
|
|
| Primary | Number of Participants With HIV Viral Load Suppression in Semen | To quantify HIV viral load suppression (<1000 copies/mL) in semen at Baseline and weeks 12, and, 24 weeks | Analysis population is limited to study participants who gave both semen and plasma specimens. This was a planned subset of all participants. Not all participants had their semen viral load measured at all time points. | Posted | Count of Participants | Participants | Baseline, Week 12, and Week 24 |
|
|
|
| Secondary | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | HIV present in blood samples from recently infected study participants was sequenced. Sequences that were similar to each other were grouped together in clusters. For this analysis, clusters were defined using a patristic distance threshold of 0.01, and a minimum cluster size of two. | Posted | Count of Participants | Participants | HIV diagnosis visit |
|
|
|
| Secondary | Percent of Participants Whose HIV Sequences Appear in Phylogenetically Defined Clusters | HIV present in blood samples from recently infected study participants was sequenced. Sequences that were similar to each other were grouped together in clusters. For this analysis, clusters were defined using a patristic distance threshold of 0.01, and a minimum cluster size of two. | Analysis population is limited to HIV-infected participants for whom HIV sequence data are available. Per initial protocol design, this analysis was conducted on all HIV sequences without dividing by randomization arm. | Posted | Number | percentage of participants | HIV diagnosis visit |
|
|
|
| Secondary | Number of Participants Diagnosed With Acute HIV Infection Who Were Linked to Care | To determine the proportion of individuals with evidence of acute infection (HIV-1 RNA-positive) who are successfully contacted for confirmatory HIV testing and are then linked to care. | Analysis population includes only those participants whose HIV infection was diagnosed during the acute phase, that is prior to HIV seroconversion. | Posted | Count of Participants | Participants | within 3 months of diagnosis of acute HIV infection |
|
|
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| Secondary | Partner Tracing | Partner tracing and notification | We were unable to trace potential partners because participants were unwilling or unable to identify recent partners | Posted | Count of Participants | Participants | within 3 months of diagnosis |
|
|
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| Secondary | Number of Participants Retained in Care | To determine the number of participants who were retained in care at weeks 12, 24, 36, and 48 | Posted | Count of Participants | Participants | Baseline, Week 12, Week 24, Week 36, and Week 48 |
|
|
|
|
| Secondary | Adherence to ART Regimen (Percentage of Pills Taken) | To determine percentage of ART pills taken by participants randomized to immediate and deferred ART initiation. | Posted | Mean | Standard Deviation | Percent of dispensed pills taken | 48 weeks |
|
|
|
|
| Secondary | Adherence to Viral Load (VL) Procedure | To determine the number of participants who had a viral load test at Baseline and weeks 12, 24, 36, and 48 | Participants still in follow up at each time point who provided viral load measurement | Posted | Count of Participants | Participants | Baseline, Week 12, Week 24, Week 36, and Week 48 |
|
|
|
|
| Secondary | Adherence to CD4 Procedure | To determine the number of participants who had a CD4 test at Baseline and weeks 12, 24, 36, and 48 | Participants still in follow up at each time point who provided a CD4 measurement | Posted | Count of Participants | Participants | Baseline, Week 12, Week 24, Week 36, and Week 48 |
|
|
|
|
| Secondary | Adherence to Questionnaires | To determine the number of participants who completed the Computer Assisted Self interviews (CASI) at Baseline and weeks 12, 24, 36, and 48 | Participants still in follow up at each time point who completed the study questionnaires | Posted | Count of Participants | Participants | Baseline, Week 12, Week 24, Week 36, and Week 48 |
|
|
|
|
| 0 |
| 105 |
| 2 |
| 105 |
| 26 |
| 105 |
| EG001 | Deferred ART (Atripla or Stribild) | Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at 24 weeks. Atripla or Stribild: Antiretroviral therapy | 0 | 111 | 1 | 111 | 28 | 111 |
| Hypotension | Vascular disorders | Non-systematic Assessment |
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| Suicidal attempt | Psychiatric disorders | Non-systematic Assessment |
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| Proctitis gonococcal | Infections and infestations | Non-systematic Assessment |
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| Syphilis | Infections and infestations | Non-systematic Assessment |
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| Genitourinary chlamydia infection | Infections and infestations | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
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| Genitourinary tract gonococcal infection | Infections and infestations | Non-systematic Assessment |
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| Pharyngitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Proctitis | Gastrointestinal disorders | Non-systematic Assessment |
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| Urethritis | Infections and infestations | Non-systematic Assessment |
|
| Hemorrhoids | General disorders | Non-systematic Assessment |
|
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| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 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 |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D000069547 | Cobicistat |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Suppressed week 12 |
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| Suppressed week 24 |
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| Missing data |
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| Audit Score >=20 |
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| Any illicit drug use |
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| Sex Work |
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| Met a sex partner at any venue |
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| Retained at Week 36 |
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| Retained at Week 48 |
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| VL at Week 12 |
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| VL at Week 24 |
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| VL at week 36 |
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| VL at Week 48 |
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| CD4 at Week 12 |
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| CD4 at Week 24 |
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| CD4 at Week 36 |
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| CD4 at Week 48 |
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| CASI at Week 12 |
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| CASI at Week 24 |
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| CASI at Week 36 |
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| CASI at Week 48 |
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