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| ID | Type | Description | Link |
|---|---|---|---|
| U01AI089244 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Mbarara University of Science and Technology | OTHER |
| Makerere University | OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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The Cryptococcal Optimal ART Timing (COAT) trial seeks to determine after cryptococcal meningitis (CM) whether early initiation of antiretroviral therapy (ART) prior to hospital discharge results in superior survival compared to standard initiation of ART started as an outpatient.
After 7-11 days of amphotericin B therapy, subjects will be randomized in a 1:1 allocation to:
HIV therapy will be with efavirenz plus nucleoside backbone per national guidelines for first line therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Earlier HIV Therapy | Experimental | HIV therapy initiated at 7-13 days of cryptococcal meningitis diagnosis. HIV therapy consisting of a nucleoside with lamivudine and efavirenz. |
|
| Deferred HIV Therapy | Active Comparator | HIV therapy initiated at 5 weeks after cryptococcal meningitis diagnosis (+/- 1 week). HIV therapy consisting of a nucleoside with lamivudine and efavirenz. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| efavirenz | Drug | Treatment strategy of when to initiate first line HIV therapy after cryptococcal meningitis diagnosis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Intention to treat analysis of 26 week survival of all subjects enrolled. Reported below are the numbers of participants who died by Week 26. | 26 weeks from study entry |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Immune Reconstitution Inflammatory Syndrome | Incidence of cryptococcal-related immune reconstitution inflammatory syndrome through 46 weeks after enrollment. | 46 weeks |
| Incidence of Cryptococcal-relapse |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants, Per CSF WBC Subgroup, Who Died by Week 26 | Percentage of Participants who died by week 26 based on CSF white blood cell (WBC) count at study entry (time of randomization at a median of 8 days of anti-fungal therapy). | 26 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David R Boulware, MD, MPH | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GF Jooste Hospital | Cape Town | South Africa | ||||
| Infectious Disease Institute, Mulago Hospital, Makerere University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24655747 | Background | Rajasingham R, Williams D, Meya DB, Meintjes G, Boulware DR, Scriven J. Nosocomial drug-resistant bacteremia in 2 cohorts with cryptococcal meningitis, Africa. Emerg Infect Dis. 2014 Apr;20(4):722-4. doi: 10.3201/eid2004.131277. No abstract available. | |
| 24399496 | Background | Carlson RD, Rolfes MA, Birkenkamp KE, Nakasujja N, Rajasingham R, Meya DB, Boulware DR. Predictors of neurocognitive outcomes on antiretroviral therapy after cryptococcal meningitis: a prospective cohort study. Metab Brain Dis. 2014 Jun;29(2):269-279. doi: 10.1007/s11011-013-9476-1. Epub 2014 Jan 9. |
| Label | URL |
|---|---|
| NIH NIAID FAQ on COAT Trial (Preliminary Results) | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Earlier HIV Therapy | HIV therapy initiated at 7-13 days after cryptococcal diagnosis |
| FG001 | Deferred HIV Therapy | HIV therapy initiated at 5 weeks after cryptococcal meningitis diagnosis (+/1 week) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
HIV-infected persons not previously receiving HIV therapy with first episode of cryptococcal meningitis diagnosed by CSF culture and/or CSF cryptococcal antigen testing.
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| ID | Title | Description |
|---|---|---|
| BG000 | Earlier HIV Therapy | HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis. |
| BG001 | Deferred HIV Therapy | HIV therapy initiated at 5 weeks after cryptococcal meningitis diagnosis (+/- 1 week) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Mortality | Intention to treat analysis of 26 week survival of all subjects enrolled. Reported below are the numbers of participants who died by Week 26. | Posted | Number | participants | 26 weeks from study entry |
|
|
46 weeks
Grade 3,4,5 adverse events were protocol specified secondary endpoint and were collected.
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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 | Earlier HIV Therapy | HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Grade 5 AEs | Nervous system disorders | DAIDS Toxicity Table | Non-systematic Assessment | Death (The number of AEs is greater than the number of persons as multiple AEs could occur simultaneously in the same participant). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematology | Blood and lymphatic system disorders | DAIDS Toxicity Table | Systematic Assessment |
The differences in mortality in the two arms were of sufficient magnitude that trial enrollment was stopped early by the Data and Safety Monitoring Board. Historically, trials stopped early routinely over-estimate the magnitude of benefit or harm.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David R Boulware | University of Minnesota | 6126249996 | coat.trial@gmail.com |
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| ID | Term |
|---|---|
| D016919 | Meningitis, Cryptococcal |
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| D003453 | Cryptococcosis |
| ID | Term |
|---|---|
| D016921 | Meningitis, Fungal |
| D020314 | Central Nervous System Fungal Infections |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C098320 | efavirenz |
| D009705 | Nucleosides |
| D015215 | Zidovudine |
| D018119 | Stavudine |
| D019259 | Lamivudine |
| ID | Term |
|---|---|
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D013936 | Thymidine |
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| University of Cape Town |
| OTHER |
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|
| nucleoside | Biological | Treatment strategy of when to initiate first line HIV therapy after cryptococcal meningitis diagnosis. |
|
|
Incidence of culture positive cryptococcal meningitis relapse
| 46 weeks |
| Safety of ART Initiation | Incidence of Adverse Events (Grade 3,4,5) through 46-weeks, as defined by the National Institute of Allergy and Infectious Diseases, Division of AIDS toxicity classification scale, version 2009. | 46 weeks |
| 46-week Survival | 46-week survival by time-to-event analysis of all subjects enrolled | 46 weeks |
| HIV-1 Viral Suppression | HIV-1 virologic suppression to <400 copies/mL at 26-weeks after enrollment | 26 weeks |
| Antiretroviral Therapy Tolerability | Incidence of antiretroviral therapy interruption by >=3 consecutive days | 26 weeks |
| Karnofsky Functional Status | Functional status via Karnofsky performance status score at 4, 26, 46 weeks. Karnofsky Scale: 100 - Normal; no complaints; no evidence of disease. 90 - Able to carry on normal activity; minor signs or symptoms of disease. 80 - Normal activity with effort; some signs or symptoms of disease. 70 - Cares for self; unable to carry on normal activity or to do active work. 60 - Requires occasional assistance, but is able to care for most of his personal needs. 50 - Requires considerable assistance and frequent medical care. 40 - Disabled; requires special care and assistance. 30 - Severely disabled; hospital admission is indicated although death not imminent. 20 - Very sick; hospital admission necessary; active supportive treatment necessary. 10 - Moribund; fatal processes progressing rapidly. 0 - Dead | 46 weeks |
| Microbiologic Clearance | Microbiologic clearance of cryptococcus as measured by serial quantitative cryptococcal cultures collected at diagnosis through 14 days of amphotericin therapy. The early fungicidal activity (EFA) of the rate of clearance is expressed as log10 colony forming units (CFU) of Cryptococcus neoformans per mL of CSF per day. | 4 weeks |
| Kampala |
| Uganda |
| Mbarara University of Science and Technology | Mbarara | Uganda |
| 24378231 | Background | Boulware DR, Rolfes MA, Rajasingham R, von Hohenberg M, Qin Z, Taseera K, Schutz C, Kwizera R, Butler EK, Meintjes G, Muzoora C, Bischof JC, Meya DB. Multisite validation of cryptococcal antigen lateral flow assay and quantification by laser thermal contrast. Emerg Infect Dis. 2014 Jan;20(1):45-53. doi: 10.3201/eid2001.130906. |
| 24065327 | Background | Kabanda T, Siedner MJ, Klausner JD, Muzoora C, Boulware DR. Point-of-care diagnosis and prognostication of cryptococcal meningitis with the cryptococcal antigen lateral flow assay on cerebrospinal fluid. Clin Infect Dis. 2014 Jan;58(1):113-6. doi: 10.1093/cid/cit641. Epub 2013 Sep 24. |
| 23945372 | Background | Robertson EJ, Najjuka G, Rolfes MA, Akampurira A, Jain N, Anantharanjit J, von Hohenberg M, Tassieri M, Carlsson A, Meya DB, Harrison TS, Fries BC, Boulware DR, Bicanic T. Cryptococcus neoformans ex vivo capsule size is associated with intracranial pressure and host immune response in HIV-associated cryptococcal meningitis. J Infect Dis. 2014 Jan 1;209(1):74-82. doi: 10.1093/infdis/jit435. Epub 2013 Aug 14. |
| 23466647 | Background | Durski KN, Kuntz KM, Yasukawa K, Virnig BA, Meya DB, Boulware DR. Cost-effective diagnostic checklists for meningitis in resource-limited settings. J Acquir Immune Defic Syndr. 2013 Jul 1;63(3):e101-8. doi: 10.1097/QAI.0b013e31828e1e56. |
| 23055838 | Background | Rajasingham R, Rolfes MA, Birkenkamp KE, Meya DB, Boulware DR. Cryptococcal meningitis treatment strategies in resource-limited settings: a cost-effectiveness analysis. PLoS Med. 2012;9(9):e1001316. doi: 10.1371/journal.pmed.1001316. Epub 2012 Sep 25. |
| 25057102 | Background | Rolfes MA, Hullsiek KH, Rhein J, Nabeta HW, Taseera K, Schutz C, Musubire A, Rajasingham R, Williams DA, Thienemann F, Muzoora C, Meintjes G, Meya DB, Boulware DR. The effect of therapeutic lumbar punctures on acute mortality from cryptococcal meningitis. Clin Infect Dis. 2014 Dec 1;59(11):1607-14. doi: 10.1093/cid/ciu596. Epub 2014 Jul 23. |
| 25651842 | Background | Scriven JE, Rhein J, Hullsiek KH, von Hohenberg M, Linder G, Rolfes MA, Williams DA, Taseera K, Meya DB, Meintjes G, Boulware DR; COAT Team. Early ART After Cryptococcal Meningitis Is Associated With Cerebrospinal Fluid Pleocytosis and Macrophage Activation in a Multisite Randomized Trial. J Infect Dis. 2015 Sep 1;212(5):769-78. doi: 10.1093/infdis/jiv067. Epub 2015 Feb 4. |
| 25838287 | Background | Williams DA, Kiiza T, Kwizera R, Kiggundu R, Velamakanni S, Meya DB, Rhein J, Boulware DR. Evaluation of fingerstick cryptococcal antigen lateral flow assay in HIV-infected persons: a diagnostic accuracy study. Clin Infect Dis. 2015 Aug 1;61(3):464-7. doi: 10.1093/cid/civ263. Epub 2015 Apr 1. |
| 25385864 | Background | Rajasingham R, Rhein J, Klammer K, Musubire A, Nabeta H, Akampurira A, Mossel EC, Williams DA, Boxrud DJ, Crabtree MB, Miller BR, Rolfes MA, Tengsupakul S, Andama AO, Meya DB, Boulware DR. Epidemiology of meningitis in an HIV-infected Ugandan cohort. Am J Trop Med Hyg. 2015 Feb;92(2):274-9. doi: 10.4269/ajtmh.14-0452. Epub 2014 Nov 10. |
| 25734161 | Background | Nabeta HW, Bahr NC, Rhein J, Fossland N, Kiragga AN, Meya DB, Dunlop SJ, Boulware DR. Accuracy of noninvasive intraocular pressure or optic nerve sheath diameter measurements for predicting elevated intracranial pressure in cryptococcal meningitis. Open Forum Infect Dis. 2014 Oct 11;1(3):ofu093. doi: 10.1093/ofid/ofu093. eCollection 2014 Dec. |
| 25492918 | Background | Meya DB, Okurut S, Zziwa G, Rolfes MA, Kelsey M, Cose S, Joloba M, Naluyima P, Palmer BE, Kambugu A, Mayanja-Kizza H, Bohjanen PR, Eller MA, Wahl SM, Boulware DR, Manabe YC, Janoff EN. Cellular immune activation in cerebrospinal fluid from ugandans with cryptococcal meningitis and immune reconstitution inflammatory syndrome. J Infect Dis. 2015 May 15;211(10):1597-606. doi: 10.1093/infdis/jiu664. Epub 2014 Dec 9. |
| 25734140 | Background | Bahr NC, Rolfes MA, Musubire A, Nabeta H, Williams DA, Rhein J, Kambugu A, Meya DB, Boulware DR. Standardized electrolyte supplementation and fluid management improves survival during amphotericin therapy for cryptococcal meningitis in resource-limited settings. Open Forum Infect Dis. 2014 Aug 25;1(2):ofu070. doi: 10.1093/ofid/ofu070. eCollection 2014 Sep. |
| 25078453 | Background | Kwizera R, Nguna J, Kiragga A, Nakavuma J, Rajasingham R, Boulware DR, Meya DB. Performance of cryptococcal antigen lateral flow assay using saliva in Ugandans with CD4 <100. PLoS One. 2014 Jul 31;9(7):e103156. doi: 10.1371/journal.pone.0103156. eCollection 2014. |
| 24963568 | Result | Boulware DR, Meya DB, Muzoora C, Rolfes MA, Huppler Hullsiek K, Musubire A, Taseera K, Nabeta HW, Schutz C, Williams DA, Rajasingham R, Rhein J, Thienemann F, Lo MW, Nielsen K, Bergemann TL, Kambugu A, Manabe YC, Janoff EN, Bohjanen PR, Meintjes G; COAT Trial Team. Timing of antiretroviral therapy after diagnosis of cryptococcal meningitis. N Engl J Med. 2014 Jun 26;370(26):2487-98. doi: 10.1056/NEJMoa1312884. |
| 39972326 | Derived | Sadiq A, Kwizera R, Kiiza TK, Ayebare P, Ahimbisibwe C, Ndyetukira JF, Boulware DR, Meya DB. Experiences, challenges, gaps, and strategies for counselling persons presenting with advanced HIV-associated meningitis in Uganda. AIDS Res Ther. 2025 Feb 19;22(1):21. doi: 10.1186/s12981-025-00705-z. |
| 32843994 | Derived | Kwizera R, Sadiq A, Ndyetukira JF, Nalintya E, Williams D, Rhein J, Boulware DR, Meya DB; COAT and ASTRO trial teams. Impact of community engagement and social support on the outcomes of HIV-related meningitis clinical trials in a resource-limited setting. Res Involv Engagem. 2020 Aug 20;6:49. doi: 10.1186/s40900-020-00228-z. eCollection 2020. |
| 31504335 | Derived | Skipper C, Schleiss MR, Bangdiwala AS, Hernandez-Alvarado N, Taseera K, Nabeta HW, Musubire AK, Lofgren SM, Wiesner DL, Rhein J, Rajasingham R, Schutz C, Meintjes G, Muzoora C, Meya DB, Boulware DR. Cytomegalovirus Viremia Associated With Increased Mortality in Cryptococcal Meningitis in Sub-Saharan Africa. Clin Infect Dis. 2020 Jul 27;71(3):525-531. doi: 10.1093/cid/ciz864. |
| 31319498 | Derived | Bayiyana A, Okurut S, Nabatanzi R, Zziwa G, Boulware DR, Lutwama F, Meya D. Longitudinal Changes in Cd4+, Cd8+ T Cell Phenotype and Activation Marker Expression Following Antiretroviral Therapy Initiation among Patients with Cryptococcal Meningitis. J Fungi (Basel). 2019 Jul 17;5(3):63. doi: 10.3390/jof5030063. |
| 30325463 | Derived | Tugume L, Rhein J, Hullsiek KH, Mpoza E, Kiggundu R, Ssebambulidde K, Schutz C, Taseera K, Williams DA, Abassi M, Muzoora C, Musubire AK, Meintjes G, Meya DB, Boulware DR; COAT and ASTRO-CM teams. HIV-Associated Cryptococcal Meningitis Occurring at Relatively Higher CD4 Counts. J Infect Dis. 2019 Feb 23;219(6):877-883. doi: 10.1093/infdis/jiy602. |
| 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 |
|
| CD4 Count, baseline | Median | Inter-Quartile Range | cells/mcL |
|
| CSF Quantitative Culture, baseline | Median | Inter-Quartile Range | log10 colony forming units/mL of CSF |
|
| CSF Cryptococcal Antigen titer, 1:xxxx | as performed by serial dilutions with lateral flow assay (LFA) | Median | Inter-Quartile Range | titers |
|
| HIV-1 Viral Load | Median | Inter-Quartile Range | log10 copies/mL |
|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Incidence of Immune Reconstitution Inflammatory Syndrome | Incidence of cryptococcal-related immune reconstitution inflammatory syndrome through 46 weeks after enrollment. | analysis is of persons who survived to initiate HIV therapy | Posted | Number | participants | 46 weeks |
|
|
|
|
| Secondary | Incidence of Cryptococcal-relapse | Incidence of culture positive cryptococcal meningitis relapse | Posted | Number | participants | 46 weeks |
|
|
|
|
| Secondary | Safety of ART Initiation | Incidence of Adverse Events (Grade 3,4,5) through 46-weeks, as defined by the National Institute of Allergy and Infectious Diseases, Division of AIDS toxicity classification scale, version 2009. | Posted | Number | participants | 46 weeks |
|
|
|
|
| Secondary | 46-week Survival | 46-week survival by time-to-event analysis of all subjects enrolled | Posted | Number | participants | 46 weeks |
|
|
|
|
| Secondary | HIV-1 Viral Suppression | HIV-1 virologic suppression to <400 copies/mL at 26-weeks after enrollment | Among persons alive at 26 weeks. 1 participant in the early ART arm had consent withdrawn by their family on day 2 after study entry. 3 participants in the deferred ART arm missing their 26 week viral load sampling. | Posted | Number | participants | 26 weeks |
|
|
|
|
| Secondary | Antiretroviral Therapy Tolerability | Incidence of antiretroviral therapy interruption by >=3 consecutive days | Analysis is of persons who survived to initiate HIV therapy. | Posted | Number | participants | 26 weeks |
|
|
|
|
| Secondary | Karnofsky Functional Status | Functional status via Karnofsky performance status score at 4, 26, 46 weeks. Karnofsky Scale: 100 - Normal; no complaints; no evidence of disease. 90 - Able to carry on normal activity; minor signs or symptoms of disease. 80 - Normal activity with effort; some signs or symptoms of disease. 70 - Cares for self; unable to carry on normal activity or to do active work. 60 - Requires occasional assistance, but is able to care for most of his personal needs. 50 - Requires considerable assistance and frequent medical care. 40 - Disabled; requires special care and assistance. 30 - Severely disabled; hospital admission is indicated although death not imminent. 20 - Very sick; hospital admission necessary; active supportive treatment necessary. 10 - Moribund; fatal processes progressing rapidly. 0 - Dead | Analysis is of persons alive at the time point. | Posted | Mean | Standard Deviation | Scores on a scale | 46 weeks |
|
|
|
|
| Secondary | Microbiologic Clearance | Microbiologic clearance of cryptococcus as measured by serial quantitative cryptococcal cultures collected at diagnosis through 14 days of amphotericin therapy. The early fungicidal activity (EFA) of the rate of clearance is expressed as log10 colony forming units (CFU) of Cryptococcus neoformans per mL of CSF per day. | All participants with >2 quantitative CSF cultures obtained | Posted | Mean | 95% Confidence Interval | log10 CFU/mL/day | 4 weeks |
|
|
|
|
| Other Pre-specified | Percentage of Participants, Per CSF WBC Subgroup, Who Died by Week 26 | Percentage of Participants who died by week 26 based on CSF white blood cell (WBC) count at study entry (time of randomization at a median of 8 days of anti-fungal therapy). | among persons with a measured CSF white cell count at randomization (Day 7-11 of amphotericin treatment) | Posted | Number | percentage of participants | 26 weeks |
|
|
|
|
| 49 |
| 88 |
| 73 |
| 88 |
| EG001 | Deferred HIV Therapy | HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week) | 53 | 89 | 75 | 89 |
|
| Grade 4 Serious AEs | Nervous system disorders | DAIDS Toxicity Table | Non-systematic Assessment | Initial Grade 4 serious AEs |
|
| Grade 3 Serious AEs | Nervous system disorders | DAIDS Toxicity Table | Non-systematic Assessment | Grade 3-5 serious AEs |
|
| Chemistries | Metabolism and nutrition disorders | DAIDS Toxicity Table | Systematic Assessment |
|
| Infection | Infections and infestations | DAIDS Toxicity Table | Systematic Assessment |
|
Not provided
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| D007239 | Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| 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 |
| D012897 | Slow Virus Diseases |
| D011741 |
| Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015224 | Dideoxynucleosides |
| D003853 | Deoxyribonucleosides |
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| 46 weeks |
|