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| Name | Class |
|---|---|
| Seattle Children's Hospital | OTHER |
| University of Nairobi | OTHER |
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The investigators propose to gauge improvements in the rate of durable suppression of viral replication by ART when OLA is used to guide clinical decisions at the PEPFAR Coptic Hope Center in Kenya, and to determine the cost-effectiveness of implementing this strategy at Coptic Hope Center.
Durable suppression of HIV replication is critical to (1) improving the health of infected individuals, (2) to reducing HIV transmission to sexual partners and from mothers to their infants, and (3) to maintaining the effectiveness of the current 1st-line non-nucleoside reverse transcriptase inhibitors (NNRTI)- based ART. Across multiple trials, individuals with NNRTI-resistance, even at low-concentrations, have substantially greater virologic failure when treated with NVP- vs PI-ART. A cost-effective strategy is needed to detect and manage ARV-resistant HIV infections. A simple low-cost innovative assay the investigators developed and successfully transferred to Asian and African countries (oligonucleotide ligation assay (OLA)) can detect NNRTI+lamivudine (3TC) resistant HIV using reagents that costs <$7.00/person. Furthermore, detection of NNRTI-resistance by OLA is highly (P<0.001) associated with virologic failure of nevirapine (NVP)-ART in two retrospective studies; one of Thai women who had been previously randomized to single-dose NVP and the second of ARV-naïve Kenyan adults.
The investigators hypothesize that implementation of OLA into routine care will allow Kenyan clinicians to appropriately target protease inhibitor (PI)-based ART and improve rates of durable suppression of viral replication, and thus improve CD4 cell gains and individuals' health, reduce the transmission of ARV-resistant HIV within the community, and maintain the utility of NNRTI-ART. In addition, the investigators hypothesize that programmatically OLA-guided ART will be more cost-efficient compared to the current strategy of empiric use of NNRTI-ART as initial treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-ART Oligonucleotide Assay (OLA) | Experimental | Pre-ART OLA will be tested for resistance at 5 pol codons conferring high-level resistance to NNRTI and 3TC (K103N, V106M, Y181C, G190A and M184V) |
|
| No OLA (Standard of Care [SOC]) | No Intervention | The participants will receive standard of care as per Kenya guidelines but will be offered OLA resistance testing after 12 months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-ART Oligonucleotide Assay (OLA) | Other | Block randomization (1:1) to pre-ART OLA testing or OLA testing after 12mo on ART |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Virologic Failure With OLA-guided ART vs. Standard of Care | The primary endpoint will be a comparison of the rates of viral non-suppression >400 copies/mL between study arms at 12 months | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Difference in Virologic Failure Among Participants With Transmitted Drug-resistance (TDR) ≥10% Associated With Use of OLA-guided ART vs. SOC | We did not analyze and report outcome of people with TDR ≥10%, instead we reported pretreatment drug resistance (PDR) as this parameter could be determined but antiretroviral history was not reliably available. Thus, PDR ≥10% is considered below in place of TDR ≥10%. Chung et al. Lancet HIV 2020; 7: e104-12. |
| Measure | Description | Time Frame |
|---|---|---|
| Descriptions of Technology Transfer of OLA to the Hope Center Laboratory, Including Intra- and Inter-assay the Reproducibility, and Discussion of Obstacles and Possible Solutions | Technology transfer of OLA to the Hope Center Laboratory in Kenya is described, including intra- and inter-assay the reproducibility, and discussion of obstacles and possible solutions. Duarte et a. AIDS 2018, 32:2301-2308 | 15 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Frenkel, MD | University of Washington, Seattle Children's Research Institute | Principal Investigator |
| Michael H Chung, MD, MPH | Department of Global Health, University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coptic Hospital | Maseno | Kenya | ||||
| Coptic Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31818716 | Derived | Chung MH, McGrath CJ, Beck IA, Levine M, Milne RS, So I, Andersen N, Dross S, Coombs RW, Chohan B, Yatich N, Kiptinness C, Sakr SR, Kiarie JN, Frenkel LM. Evaluation of the management of pretreatment HIV drug resistance by oligonucleotide ligation assay: a randomised controlled trial. Lancet HIV. 2020 Feb;7(2):e104-e112. doi: 10.1016/S2352-3018(19)30337-6. Epub 2019 Dec 7. | |
| 29040633 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-ART Oligonucleotide Assay (OLA) | Pre-ART OLA will be tested for resistance at 5 pol codons conferring high-level resistance to NNRTI and 3TC (K103N, V106M, Y181C, G190A and M184V) Pre-ART Oligonucleotide Assay (OLA): Block randomization (1:1) to pre-ART OLA testing or OLA testing after 12mo on ART |
| FG001 | No OLA (Standard of Care [SOC]) | The participants will receive standard of care as per Kenya guidelines but will be offered OLA resistance testing after 12 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pre-ART Oligonucleotide Assay (OLA) | Pre-ART OLA will be tested for resistance at 5 pol codons conferring high-level resistance to NNRTI and 3TC (K103N, V106M, Y181C, G190A and M184V) Pre-ART Oligonucleotide Assay (OLA): Block randomization (1:1) to pre-ART OLA testing or OLA testing after 12mo on ART |
| BG001 |
| 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 | Number of Participants With Virologic Failure With OLA-guided ART vs. Standard of Care | The primary endpoint will be a comparison of the rates of viral non-suppression >400 copies/mL between study arms at 12 months | Posted | Count of Participants | Participants | 12 months |
|
2 years
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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 | Pre-ART Oligonucleotide Assay (OLA) | Pre-ART OLA will be tested for resistance at 5 pol codons conferring high-level resistance to NNRTI and 3TC (K103N, V106M, Y181C, G190A and M184V) Pre-ART Oligonucleotide Assay (OLA): Block randomization (1:1) to pre-ART OLA testing or OLA testing after 12mo on ART |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bloating | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Lisa Frenkel | University of Washington | +1 206 987-5140 | lfrenkel@uw.edu |
Not provided
| ID | Term |
|---|---|
| D006679 | HIV Seropositivity |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| 15 months |
| Difference in Virologic Failure in the Subgroup of Participants With Prior or Ongoing ART Use Associated With Use of OLA-guided ART vs. SOC | The primary outcome was virologic failure defined as plasma HIV RNA of at least 400 copies per mL after initiation of antiretroviral therapy (ART). | 15 months |
| Prevalence of TDR by Consensus Sequencing and OLA | We did not analyze and report outcome of people with TDR, instead we reported pretreatment drug resistance (PDR) as this parameter could be determined but antiretroviral history was not reliably available. Thus, PDR is considered below in place of TDR. PDR was assessed by OLA and confirmed by consensus sequence or next-generation sequencing. | 15 months |
| Proportion of Subgroup With TDR With Virologic Failure by Randomization Arm | We did not analyze and report outcome of people with TDR, instead we reported pretreatment drug resistance (PDR) as this parameter could be determined but antiretroviral history was not reliably available. Thus, PDR is considered below in place of TDR. The primary outcome for this analysis was the difference in virologic failure, defined as plasma HIV-1 RNA of at least 400 copies per mL following ART initiation, by PDR. [Chung et al. Lancet HIV 2020; 7: e104-12] | 15 months |
| Estimates of Medical Resource Utilization During the One-year Trial Period | Estimates of medical resource utilization during was not calculated. No data available (data on medical resource utilization was not collected during the one-year trial) | 15 months |
| An Assessment of the Potential Long-term Cost-effectiveness of OLA-guided Testing Over a Patient's Lifetime | This was not calculated as the model could not test for a period longer than 15 years due to computing limitations. | 15 months |
| Determination of Whether Low-level ARV Resistance (<5%) Detected by PYRO But Not by OLA is Associated With Virologic Failure | The prespecified outcomes of this study included differences in the rate of virologic failure over 24 months of efavirenz-based ART between participants by frequency of drug-resistant variants detected by next-generation sequencing at enrollment. Drug-resistance frequency was defined as the proportion of a nucleotide variant encoding a drug-resistant codon in specimens with at least 100 viral templates sequenced. Virologic failure was defined as plasma HIV RNA of at least 400 copies/ml in sequential specimens or at the final study visit in participants prescribed efavirenz-based ART. [Milne et al. AIDS 2022 Nov 15;36(14):1949-1958] | 24 months |
| A Comparison of OLA Results Obtained Using DBS in Kenya to Retesting of Same Specimens With Input of Viral Templates Measured in Seattle | DBS were not tested in Kenya and thus, the comparison of OLA results obtained using DBS in Kenya to retesting of same specimens with input of viral templates measured in Seattle was not evaluated. | 15 months |
| Detection of Resistance Mutations at OLA Codons by OLA vs. Consensus Sequencing | Rates of pre-treatment drug resistance among all study participants in the study were assessed by OLA but not by consensus sequencing (CS) due to the high cost of sequencing the entire population. However, all mutations detected by OLA were confirmed by CS in Seattle, and if not detected by CS were confirmed by next generation Illumina sequencing. Participants with any indeterminate OLA results were also sequenced to determine the genotype at the indeterminate codon. | Enrollment |
| Nairobi |
| Kenya |
| Derived |
| Silverman RA, Beck IA, Kiptinness C, Levine M, Milne R, McGrath CJ, Bii S, Richardson BA, John-Stewart G, Chohan B, Sakr SR, Kiarie JN, Frenkel LM, Chung MH. Prevalence of Pre-antiretroviral-Treatment Drug Resistance by Gender, Age, and Other Factors in HIV-Infected Individuals Initiating Therapy in Kenya, 2013-2014. J Infect Dis. 2017 Dec 19;216(12):1569-1578. doi: 10.1093/infdis/jix544. |
| No OLA (Standard of Care [SOC]) |
The participants will receive standard of care as per Kenya guidelines but will be offered OLA resistance testing after 12 months |
| 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 |
|
|
|
| Secondary | The Difference in Virologic Failure Among Participants With Transmitted Drug-resistance (TDR) ≥10% Associated With Use of OLA-guided ART vs. SOC | We did not analyze and report outcome of people with TDR ≥10%, instead we reported pretreatment drug resistance (PDR) as this parameter could be determined but antiretroviral history was not reliably available. Thus, PDR ≥10% is considered below in place of TDR ≥10%. Chung et al. Lancet HIV 2020; 7: e104-12. | WHO defines pretreatment HIV drug resistance (PDR) as "DR that is detected in ARV drug-naive people initiating ART or people with prior ARV drug exposure initiating or reinitiating first-line ART. PDR is either transmitted or acquired drug resistance, or both". Thus, we did not report outcomes with TDR, instead we reported PDR as this could be determined but antiretroviral history was not available. Thus, PDR is reported in place of TDR. This included participants with PDR ≥10% at randomization. | Posted | Count of Participants | Participants | 15 months |
|
|
|
| Secondary | Difference in Virologic Failure in the Subgroup of Participants With Prior or Ongoing ART Use Associated With Use of OLA-guided ART vs. SOC | The primary outcome was virologic failure defined as plasma HIV RNA of at least 400 copies per mL after initiation of antiretroviral therapy (ART). | The analysis population included only those participants that had prior or ongoing ART use (non-ARV naive) at randomization. | Posted | Count of Participants | Participants | 15 months |
|
|
|
| Secondary | Prevalence of TDR by Consensus Sequencing and OLA | We did not analyze and report outcome of people with TDR, instead we reported pretreatment drug resistance (PDR) as this parameter could be determined but antiretroviral history was not reliably available. Thus, PDR is considered below in place of TDR. PDR was assessed by OLA and confirmed by consensus sequence or next-generation sequencing. | WHO defines pretreatment HIV drug resistance (PDR) as "DR that is detected in ARV drug-naive people initiating ART or people with prior ARV drug exposure initiating or reinitiating first-line ART". Thus, we did not report outcomes with TDR, instead we reported PDR as this could be determined but antiretroviral history was not available. Thus, PDR is reported in place of TDR. This analysis included participants with PDR assessed by OLA and confirmed by consensus sequencing by study arm. | Posted | Count of Participants | Participants | 15 months |
|
|
|
| Secondary | Proportion of Subgroup With TDR With Virologic Failure by Randomization Arm | We did not analyze and report outcome of people with TDR, instead we reported pretreatment drug resistance (PDR) as this parameter could be determined but antiretroviral history was not reliably available. Thus, PDR is considered below in place of TDR. The primary outcome for this analysis was the difference in virologic failure, defined as plasma HIV-1 RNA of at least 400 copies per mL following ART initiation, by PDR. [Chung et al. Lancet HIV 2020; 7: e104-12] | WHO defines pretreatment HIV drug resistance (PDR) as "DR that is detected in ARV drug-naive people initiating ART or people with prior ARV drug exposure initiating or reinitiating first-line ART". Thus, we did not report outcomes with TDR, instead we reported PDR as this could be determined but antiretroviral history was not available. Thus, PDR is reported in place of TDR. The population included the subgroup of participants with PDR in each study arm. | Posted | Count of Participants | Participants | 15 months |
|
|
|
| Secondary | Estimates of Medical Resource Utilization During the One-year Trial Period | Estimates of medical resource utilization during was not calculated. No data available (data on medical resource utilization was not collected during the one-year trial) | No data available (data on medical resource utilization was not collected). | Posted | 15 months |
|
|
| Secondary | An Assessment of the Potential Long-term Cost-effectiveness of OLA-guided Testing Over a Patient's Lifetime | This was not calculated as the model could not test for a period longer than 15 years due to computing limitations. | This was not calculated as the model could not test for a period longer than 15 years due to computing limitations. | Posted | 15 months |
|
|
| Secondary | Determination of Whether Low-level ARV Resistance (<5%) Detected by PYRO But Not by OLA is Associated With Virologic Failure | The prespecified outcomes of this study included differences in the rate of virologic failure over 24 months of efavirenz-based ART between participants by frequency of drug-resistant variants detected by next-generation sequencing at enrollment. Drug-resistance frequency was defined as the proportion of a nucleotide variant encoding a drug-resistant codon in specimens with at least 100 viral templates sequenced. Virologic failure was defined as plasma HIV RNA of at least 400 copies/ml in sequential specimens or at the final study visit in participants prescribed efavirenz-based ART. [Milne et al. AIDS 2022 Nov 15;36(14):1949-1958] | Analysis included 352 participants from Nairobi, including 332 with virologic suppression at month-12 of efavirenz-based ART who enrolled for a second year and 20 participants who experienced virologic failure by month-12 of efavirenz-based ART. Pretreatment drug-resistance was classified as: wild-type (0%), low-frequency (1-9%), high-frequency (10-100%). Virologic failure by month-24 of efavirenz-based ART, was compared between individuals with and without pretreatment drug-resistance. | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Other Pre-specified | Descriptions of Technology Transfer of OLA to the Hope Center Laboratory, Including Intra- and Inter-assay the Reproducibility, and Discussion of Obstacles and Possible Solutions | Technology transfer of OLA to the Hope Center Laboratory in Kenya is described, including intra- and inter-assay the reproducibility, and discussion of obstacles and possible solutions. Duarte et a. AIDS 2018, 32:2301-2308 | Technology transfer to Kenya is described, including quality control measures and a discussion of issues. Duarte et a. AIDS 2018, 32:2301-2308 | Posted | 15 months |
|
|
| Other Pre-specified | A Comparison of OLA Results Obtained Using DBS in Kenya to Retesting of Same Specimens With Input of Viral Templates Measured in Seattle | DBS were not tested in Kenya and thus, the comparison of OLA results obtained using DBS in Kenya to retesting of same specimens with input of viral templates measured in Seattle was not evaluated. | DBS were not tested in Kenya. | Posted | 15 months |
|
|
| Other Pre-specified | Detection of Resistance Mutations at OLA Codons by OLA vs. Consensus Sequencing | Rates of pre-treatment drug resistance among all study participants in the study were assessed by OLA but not by consensus sequencing (CS) due to the high cost of sequencing the entire population. However, all mutations detected by OLA were confirmed by CS in Seattle, and if not detected by CS were confirmed by next generation Illumina sequencing. Participants with any indeterminate OLA results were also sequenced to determine the genotype at the indeterminate codon. | Among the subgroup of enrollment samples with both OLA and CS testing, we compared mutation detection by each method at OLA codons and assessed mutations at non-OLA codons detected by CS. Only mutations with Stanford HIVDR Program drug resistance mutation scores ≥10 were included. | Posted | Count of Participants | Participants | Enrollment |
|
|
|
| 34 |
| 492 |
| 39 |
| 492 |
| 32 |
| 492 |
| EG001 | No OLA (Standard of Care [SOC]) | The participants will receive standard of care as per Kenya guidelines but will be offered OLA resistance testing after 12 months | 43 | 495 | 34 | 495 | 26 | 495 |
| Cryptococcal Meningitis | Infections and infestations | Non-systematic Assessment |
|
| Stevens Johnson Syndrome | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Amoebiasis | Infections and infestations | Non-systematic Assessment |
|
| Bell's Palsy | Nervous system disorders | Non-systematic Assessment |
|
| Blocked Fallopian Tubes | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Chest Pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Childbirth | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Esophageal Candidiasis | Infections and infestations | Non-systematic Assessment |
|
| Fibroids | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Gastric Ulcers | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal distress | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Hemorrhoidectomy | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hysterectomy | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Incontinence | Renal and urinary disorders | Non-systematic Assessment |
|
| Kaposi Sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Low Blood Pressure | Cardiac disorders | Systematic Assessment |
|
| Menigitis | Infections and infestations | Non-systematic Assessment |
|
| Nail Discoloration | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Peptic Ulcer Disease | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rectal Bleeding | Gastrointestinal disorders | Systematic Assessment |
|
| Road Traffic Accident | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Syncope | Nervous system disorders | Non-systematic Assessment |
|
| Tuberculosis | Infections and infestations | Non-systematic Assessment |
|
| Threatened Abortion | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Thyroidectomy | Endocrine disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Bloody Stool | Gastrointestinal disorders | Non-systematic Assessment |
|
| Blurred Vision | Eye disorders | Systematic Assessment |
|
| Chest Pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Childbirth | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
|
| Genital Ulcer | Infections and infestations | Systematic Assessment |
|
| Goiter | Endocrine disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Joint Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Lip Swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Malaria | Infections and infestations | Non-systematic Assessment |
|
| Mouth Ulcer | Gastrointestinal disorders | Systematic Assessment |
|
| Nail Discoloration | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Oral Candidiasis | Infections and infestations | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | Systematic Assessment |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Road Traffic Accident | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Sore Throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Tuberculosis | Infections and infestations | Non-systematic Assessment |
|
| Tonsilitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
Not provided
| 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 |
| High-frequency resistance |
|
| G190A |
|
| K65R |
|
| M184V |
|
| Not detected |
|