Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| BOTUSA MB06 | Other Identifier | CDC-BOTUSA |
Not provided
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| Name | Class |
|---|---|
| Botswana Ministry of Health | OTHER_GOV |
| Gilead Sciences | INDUSTRY |
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This study tested whether taking a pill of tenofovir and emtricitabine (two antiretroviral medicines) was safe for sexually-active young adults in Botswana without HIV infection and whether it reduced their risk of getting an HIV infection.
Twelve hundred and nineteen healthy, sexually active women and men, 18-39 years old, without HIV infection were enrolled in Francistown and Gaborone, Botswana. They were provided with free male and female condoms, repeated individualized risk-reduction counseling, diagnosis and treatment of sexually transmitted diseases, and women will be provided with a choice of effective family planning methods. In addition, volunteers were randomized to receive either Tenofovir and emtricitabine (in a single pill) or a placebo pill to take once a day. Volunteers were seen monthly for at least 12 months to monitor for side effects and toxicities and to test their HIV status. Persons who become HIV infected during the trial received ongoing supportive counseling, CD4 and viral load monitoring, education about HIV infection/disease, and access to HIV care including free antiretrovirals when clinically indicated. Volunteer safety was monitored by a local ethics committee, Centers for Disease Control Institutional Review Board (CDC IRB) and an independent data safety and monitoring board
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TDF-FTC,condoms,adh/risk counseling | Active Comparator | Eligible participants were randomized to oral Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg (TDF-FTC) once daily in the form of a single tablet. The ratio of randomization was 1:1. Participants randomized to the active arm received male and female condoms, risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. |
|
| Placebo,condoms,adh/risk counseling | Placebo Comparator | Eligible participants were randomized to the placebo arm and received placebo oral tablets that were visually identical to the TDF-FTC tablet and taken once daily. The placebo tablets contained no active ingredients. The ratio of randomization was 1:1. Participants randomized to the placebo arm received male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Drug Reactions in the Tenofovir/Emtricitabine and Placebo Arms | Study visits were scheduled every 30 days until completion of the study, and participants were instructed to return to the clinic for evaluation in the event of an illness. Participants reported any adverse effects at monthly visits and interim visits. | Monthly, for up to 3 years |
| HIV Incidence in the Tenofovir/Emtricitabine and Placebo Arms | Study visits were scheduled every 30 days until completion of the study and during monthly study visits, we performed testing for HIV infection. At completion of the study, we tested all participants for HIV infection, using an enzyme-linked immunosorbent assay (ELISA).The primary efficacy end point was the difference in the rates of HIV infection between participants assigned to receive TDF-FTC and those assigned to receive placebo. The initial efficacy analysis included all study participants who were randomly assigned to receive a study medication (intention-to-treat cohort). | Monthly, for up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts | We assessed condom use of the enrolled participants by face-to-face interviews (at baseline and monthly thereafter) and provided a comprehensive package of HIV prevention services, including individualized counseling on risk reduction, free male and female condoms, and screening for sexually transmitted infections followed, if applicable, by partner notification and treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Thigpen, MD MPH | National Institutes of Health (NIH) | Principal Investigator |
| Lynn Paxton, MD MPH | Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centers for Disease Control and Prevention | Atlanta | Georgia | 30333 | United States | ||
| BOTUSA HIV Prevention Research Unit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26767149 | Background | Toledo L, McLellan-Lemal E, Henderson FL, Kebaabetswe PM. Knowledge, Attitudes, and Experiences of HIV Pre-Exposure Prophylaxis (PrEP) Trial Participants in Botswana. World J AIDS. 2015 Mar;5(2):10-20. doi: 10.4236/wja.2015.51002. Epub 2015 Feb 12. | |
| 24625530 | Background | Kasonde M, Niska RW, Rose C, Henderson FL, Segolodi TM, Turner K, Smith DK, Thigpen MC, Paxton LA. Bone mineral density changes among HIV-uninfected young adults in a randomised trial of pre-exposure prophylaxis with tenofovir-emtricitabine or placebo in Botswana. PLoS One. 2014 Mar 13;9(3):e90111. doi: 10.1371/journal.pone.0090111. eCollection 2014. |
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Data sharing will be governed by prevailing CDC data sharing policies.
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| ID | Title | Description |
|---|---|---|
| FG000 | TDF-FTC, Condoms, Risk Counseling | Participants randomized to the active arm received daily oral TDF-FTC along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg: Daily oral single dose pill containing 300 mg TDF and 200 mg FTC. |
| FG001 | Placebo, Condoms, Risk Counseling | Participants randomized to the placebo arm received a daily oral placebo tablet along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. TDF-FTC placebo: Placebo comparator for TDF-FTC |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 1219 underwent randomization. Of the 611 assigned to TDF-FTC: 9 did not start TDF-FTC and 1 was HIV-infected at enrollment. Of the 608 assigned to placebo: 7 did not start placebo and 2 were HIV-infected at enrollment.
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| ID | Title | Description |
|---|---|---|
| BG000 | TDF-FTC, Condoms, Risk Counseling | Participants randomized to the active arm received daily oral TDF-FTC along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg: Daily oral single dose pill containing 300 mg TDF and 200 mg FTC. |
| 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 | Percentage of Participants With Adverse Drug Reactions in the Tenofovir/Emtricitabine and Placebo Arms | Study visits were scheduled every 30 days until completion of the study, and participants were instructed to return to the clinic for evaluation in the event of an illness. Participants reported any adverse effects at monthly visits and interim visits. | Posted | Number | percentage of participants with AE | Monthly, for up to 3 years |
|
Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years.
Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
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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 | TDF-FTC, Condoms, Risk Counseling | Participants randomized to the active arm received daily oral TDF-FTC along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg: Daily oral single dose pill containing 300 mg TDF and 200 mg FTC. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated ALT | Hepatobiliary disorders | ICD9-CM | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal Menses | Reproductive system and breast disorders | ICD9-CM | Non-systematic Assessment |
The rates of study completion were lower than predicted because more participants withdrew from the study, mostly due to relocation or conflicting obligations.Findings may not be generalizable to other populations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Thigpen | National Institutes of Health | 1-240-669-2877 | michael.thigpen@nih.gov |
Not provided
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D000068679 | Emtricitabine |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo Oral Tablet |
| Drug |
|
|
| 12 months |
| Rates of Adherence to Study Medication | The rates of adherence to study medication by treatment arm was assessed over the entire course of the study. This comparison was done by assessing the percentage of pills taken by participants within each study arm. The difference between the 2 arms was compared with a Fisher' exact test. | 36 months |
| Antiretroviral (ARV) Resistance Patterns in Seroconverters | Participants who seroconverted had blood samples taken at the time of infection and at one month and six months post seroconversion to detect any HIV resistance mutations. | At time HIV infection diagnosed,1 month post-time of HIV infection diagnosis, and 6 months post-time of HIV infection diagnosis |
| CD4 Evaluation After HIV Seroconversion | Study medication was stopped when HIV infected was diagnosed. Seroconvertors were referred for clinical care and followed an additional year with scheduled quarterly CD4+ cell count assessments. A model-estimated geometric mean of the CD4+ cell counts by each treatment group was evaluated. | 1-year post seroconversion |
| Gaborone |
| Botswana |
| 24361682 | Background | Chirwa LI, Johnson JA, Niska RW, Segolodi TM, Henderson FL, Rose CE, Li JF, Thigpen MC, Matlhaba O, Paxton LA, Brooks JT. CD4(+) cell count, viral load, and drug resistance patterns among heterosexual breakthrough HIV infections in a study of oral preexposure prophylaxis. AIDS. 2014 Jan 14;28(2):223-6. doi: 10.1097/QAD.0000000000000102. |
| 25186785 | Background | Kebaabetswe PM, Stirratt MJ, McLellan-Lemal E, Henderson FL, Gray SC, Rose CE, Williams T, Paxton LA. Factors Associated with Adherence and Concordance Between Measurement Strategies in an HIV Daily Oral Tenofovir/Emtricitibine as Pre-exposure Prophylaxis (Prep) Clinical Trial, Botswana, 2007-2010. AIDS Behav. 2015 May;19(5):758-69. doi: 10.1007/s10461-014-0891-z. |
| 24714095 | Background | Segolodi TM, Henderson FL, Rose CE, Turner KT, Zeh C, Fonjungo PN, Niska R, Hart C, Paxton LA. Normal laboratory reference intervals among healthy adults screened for a HIV pre-exposure prophylaxis clinical trial in Botswana. PLoS One. 2014 Apr 8;9(4):e93034. doi: 10.1371/journal.pone.0093034. eCollection 2014. |
| 22784038 | Result | Thigpen MC, Kebaabetswe PM, Paxton LA, Smith DK, Rose CE, Segolodi TM, Henderson FL, Pathak SR, Soud FA, Chillag KL, Mutanhaurwa R, Chirwa LI, Kasonde M, Abebe D, Buliva E, Gvetadze RJ, Johnson S, Sukalac T, Thomas VT, Hart C, Johnson JA, Malotte CK, Hendrix CW, Brooks JT; TDF2 Study Group. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med. 2012 Aug 2;367(5):423-34. doi: 10.1056/NEJMoa1110711. Epub 2012 Jul 11. |
| 27509251 | Result | Gust DA, Soud F, Hardnett FP, Malotte CK, Rose C, Kebaabetswe P, Makgekgenene L, Henderson F, Paxton L, Segolodi T, Kilmarx PH. Evaluation of Sexual Risk Behavior Among Study Participants in the TDF2 PrEP Study Among Heterosexual Adults in Botswana. J Acquir Immune Defic Syndr. 2016 Dec 15;73(5):556-563. doi: 10.1097/QAI.0000000000001143. |
| Relocated |
|
| Were withdrawn by investigator |
|
| Death |
|
| Had other reasons |
|
| HIV-infected at enrollment |
|
| Never started drug |
|
| BG001 | Placebo, Condoms, Risk Counseling | Participants randomized to the placebo arm received a daily oral placebo tablet along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. TDF-FTC placebo: Placebo comparator for TDF-FTC |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Placebo, Condoms, Risk Counseling |
Participants randomized to the placebo arm received a daily oral placebo tablet along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. TDF-FTC placebo: Placebo comparator for TDF-FTC |
|
|
|
| Primary | HIV Incidence in the Tenofovir/Emtricitabine and Placebo Arms | Study visits were scheduled every 30 days until completion of the study and during monthly study visits, we performed testing for HIV infection. At completion of the study, we tested all participants for HIV infection, using an enzyme-linked immunosorbent assay (ELISA).The primary efficacy end point was the difference in the rates of HIV infection between participants assigned to receive TDF-FTC and those assigned to receive placebo. The initial efficacy analysis included all study participants who were randomly assigned to receive a study medication (intention-to-treat cohort). | Of the 1219, 3 were excluded from analysis because HIV-infected at the time of enrollment. | Posted | Number | infections/100 person-years | Monthly, for up to 3 years |
|
|
|
|
| Secondary | Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts | We assessed condom use of the enrolled participants by face-to-face interviews (at baseline and monthly thereafter) and provided a comprehensive package of HIV prevention services, including individualized counseling on risk reduction, free male and female condoms, and screening for sexually transmitted infections followed, if applicable, by partner notification and treatment. | Of 1219, 19 excluded (3 HIV-infected at enrollment, 16 never started drug). Of the 1200, 24 reported no sex during study. Remaining total 1176 with >=1 sex act included in analysis. | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| Secondary | Rates of Adherence to Study Medication | The rates of adherence to study medication by treatment arm was assessed over the entire course of the study. This comparison was done by assessing the percentage of pills taken by participants within each study arm. The difference between the 2 arms was compared with a Fisher' exact test. | Posted | Mean | Standard Deviation | Percentage of pills taken | 36 months |
|
|
|
|
| Secondary | Antiretroviral (ARV) Resistance Patterns in Seroconverters | Participants who seroconverted had blood samples taken at the time of infection and at one month and six months post seroconversion to detect any HIV resistance mutations. | Posted | Count of Participants | Participants | No | At time HIV infection diagnosed,1 month post-time of HIV infection diagnosis, and 6 months post-time of HIV infection diagnosis |
|
|
|
| Secondary | CD4 Evaluation After HIV Seroconversion | Study medication was stopped when HIV infected was diagnosed. Seroconvertors were referred for clinical care and followed an additional year with scheduled quarterly CD4+ cell count assessments. A model-estimated geometric mean of the CD4+ cell counts by each treatment group was evaluated. | Posted | Geometric Mean | 95% Confidence Interval | cells/microliter | 1-year post seroconversion |
|
|
|
| 42 |
| 611 |
| 557 |
| 611 |
| EG001 | Placebo, Condoms, Risk Counseling | Participants randomized to the placebo arm received a daily oral placebo tablet along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. TDF-FTC placebo: Placebo comparator for TDF-FTC | 44 | 608 | 536 | 608 |
| Hyperamylasemia | Endocrine disorders | ICD9-CM | Non-systematic Assessment |
|
| Hyperchloremia | General disorders | ICD9-CM | Non-systematic Assessment |
|
| Elevated creatinine | Renal and urinary disorders | ICD9-CM | Non-systematic Assessment |
|
| Hypophosphatemia | Renal and urinary disorders | ICD9-CM | Non-systematic Assessment |
|
| Hyperkalemia | Renal and urinary disorders | ICD9-CM | Non-systematic Assessment |
|
| Hypernatremia | Renal and urinary disorders | ICD9-CM | Non-systematic Assessment |
|
| Chest Pain | Cardiac disorders | ICD9-CM | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | ICD9-CM | Non-systematic Assessment |
|
| Fracture | Musculoskeletal and connective tissue disorders | ICD9-CM | Non-systematic Assessment |
|
| Headache | General disorders | ICD9-CM | Non-systematic Assessment |
|
| Injury, non-fatal | Musculoskeletal and connective tissue disorders | ICD9-CM | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | ICD9-CM | Non-systematic Assessment |
|
| Tonsillitis, acute | Infections and infestations | ICD9-CM | Non-systematic Assessment |
|
| Wound | Skin and subcutaneous tissue disorders | ICD9-CM | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | ICD9-CM | Non-systematic Assessment |
|
| Abscess | Skin and subcutaneous tissue disorders | ICD9-CM | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | ICD9-CM | Non-systematic Assessment |
|
| Allergy, unspecified | General disorders | ICD9-CM | Non-systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | ICD9-CM | Non-systematic Assessment |
|
| Balanitis | Reproductive system and breast disorders | ICD9-CM | Non-systematic Assessment |
|
| Bite | Injury, poisoning and procedural complications | ICD9-CM | Non-systematic Assessment |
|
| Breast Abnormalities | Reproductive system and breast disorders | ICD9-CM | Non-systematic Assessment |
|
| Chest Pain | Cardiac disorders | ICD9-CM | Non-systematic Assessment |
|
| Chlamydia | Reproductive system and breast disorders | ICD9-CM | Non-systematic Assessment |
|
| Upper Respiratory Infection | Infections and infestations | ICD9-CM | Non-systematic Assessment |
|
| Conjuctivitis | Eye disorders | ICD9-CM | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | ICD9-CM | Non-systematic Assessment |
|
| Contusion | Skin and subcutaneous tissue disorders | ICD9-CM | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | ICD9-CM | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | ICD9-CM | Non-systematic Assessment |
|
| Dermatomycosis | Skin and subcutaneous tissue disorders | ICD9-CM | Non-systematic Assessment |
|
| Dermatophytosis | Skin and subcutaneous tissue disorders | ICD9-CM | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | ICD9-CM | Non-systematic Assessment |
|
| Disturbance of Skin Sensation | Skin and subcutaneous tissue disorders | ICD9-CM | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | ICD9-CM | Non-systematic Assessment |
|
| Dysmenorrhea | Reproductive system and breast disorders | ICD9-CM | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | ICD9-CM | Non-systematic Assessment |
|
| Edema, limb | Skin and subcutaneous tissue disorders | ICD9-CM | Non-systematic Assessment |
|
| Epistaxis | General disorders | ICD9-CM | Non-systematic Assessment |
|
| Fatigue | General disorders | ICD9-CM | Non-systematic Assessment |
|
| Fever | General disorders | ICD9-CM | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | ICD9-CM | Non-systematic Assessment |
|
| Folliculitis | Skin and subcutaneous tissue disorders | ICD9-CM | Non-systematic Assessment |
|
| Fracture | Musculoskeletal and connective tissue disorders | ICD9-CM | Non-systematic Assessment |
|
| Gastroesophageal Reflux | Gastrointestinal disorders | ICD9-CM | Non-systematic Assessment |
|
| Generalized Pain | General disorders | ICD9-CM | Non-systematic Assessment |
|
| Genital Herpes | Reproductive system and breast disorders | ICD9-CM | Non-systematic Assessment |
|
| Gonorrhea | Reproductive system and breast disorders | ICD9-CM | Non-systematic Assessment |
|
| Headache | General disorders | ICD9-CM | Non-systematic Assessment |
|
| Hypertension | Cardiac disorders | ICD9-CM | Non-systematic Assessment |
|
| Hypotension | Cardiac disorders | ICD9-CM | Non-systematic Assessment |
|
| Injury, Nonfatal | Injury, poisoning and procedural complications | ICD9-CM | Non-systematic Assessment |
|
| Leukorrhea | Reproductive system and breast disorders | ICD9-CM | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | ICD9-CM | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | ICD9-CM | Non-systematic Assessment |
|
| Oral Disease, Gingiva | General disorders | ICD9-CM | Non-systematic Assessment |
|
| Oral Disease, Teeth | General disorders | ICD9-CM | Non-systematic Assessment |
|
| Pain, Ear | Ear and labyrinth disorders | ICD9-CM | Non-systematic Assessment |
|
| Pain, Abdominal | Gastrointestinal disorders | ICD9-CM | Non-systematic Assessment |
|
| Pain, Acute Musculoskeletal | Musculoskeletal and connective tissue disorders | ICD9-CM | Non-systematic Assessment |
|
| Pain, Back | Musculoskeletal and connective tissue disorders | ICD9-CM | Non-systematic Assessment |
|
| Pain, Genital | Reproductive system and breast disorders | ICD9-CM | Non-systematic Assessment |
|
| Pain, Joint | Musculoskeletal and connective tissue disorders | ICD9-CM | Non-systematic Assessment |
|
| Pain, Limb | Musculoskeletal and connective tissue disorders | ICD9-CM | Non-systematic Assessment |
|
| Painful Eyes | Eye disorders | ICD9-CM | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | ICD9-CM | Non-systematic Assessment |
|
| Pelvic Inflammatory Disease | Reproductive system and breast disorders | ICD9-CM | Non-systematic Assessment |
|
| Pharyngitis, Acute | General disorders | ICD9-CM | Non-systematic Assessment |
|
| Polyphagia | Endocrine disorders | ICD9-CM | Non-systematic Assessment |
|
| Pruritus, Genital | Reproductive system and breast disorders | ICD9-CM | Non-systematic Assessment |
|
| Pruritus, Unspecified | Skin and subcutaneous tissue disorders | ICD9-CM | Non-systematic Assessment |
|
| Rash, Unspecified | Skin and subcutaneous tissue disorders | ICD9-CM | Non-systematic Assessment |
|
| Rhinitis | General disorders | ICD9-CM | Non-systematic Assessment |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | ICD9-CM | Non-systematic Assessment |
|
| Sore Ulcer, Genital | Reproductive system and breast disorders | ICD9-CM | Non-systematic Assessment |
|
| Sore Ulcer, Oral Cavity | Skin and subcutaneous tissue disorders | ICD9-CM | Non-systematic Assessment |
|
| Tonsilitis, Acute | General disorders | ICD9-CM | Non-systematic Assessment |
|
| Trichomoniasis | Reproductive system and breast disorders | ICD9-CM | Non-systematic Assessment |
|
| Urethral Discharge | Reproductive system and breast disorders | ICD9-CM | Non-systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | ICD9-CM | Non-systematic Assessment |
|
| Vaginal Candidiasis | Reproductive system and breast disorders | ICD9-CM | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | ICD9-CM | Non-systematic Assessment |
|
| Wound | Skin and subcutaneous tissue disorders | ICD9-CM | Non-systematic Assessment |
|
| Blood Urea Nitrogen | Renal and urinary disorders | ICD9-CM | Non-systematic Assessment |
|
| Phosphate | Blood and lymphatic system disorders | ICD9-CM | Non-systematic Assessment |
|
| Amylase, Serum | Gastrointestinal disorders | ICD9-CM | Non-systematic Assessment |
|
| AST/SGOT | Gastrointestinal disorders | ICD9-CM | Non-systematic Assessment |
|
| ALT/SGPT | Gastrointestinal disorders | ICD9-CM | Non-systematic Assessment |
|
| Bilirubin, total | Blood and lymphatic system disorders | ICD9-CM | Non-systematic Assessment |
|
| Bilirubin, direct | Gastrointestinal disorders | ICD9-CM | Non-systematic Assessment |
|
| Sodium | Blood and lymphatic system disorders | ICD9-CM | Non-systematic Assessment |
|
| Potassium | Blood and lymphatic system disorders | ICD9-CM | Non-systematic Assessment |
|
| Bicarbonate | Blood and lymphatic system disorders | ICD9-CM | Non-systematic Assessment |
|
| Chloride | Blood and lymphatic system disorders | ICD9-CM | Non-systematic Assessment |
|
Not provided
Not provided
| 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 |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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| Month 12 |
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