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| Name | Class |
|---|---|
| Kilimanjaro Christian Medical Centre, Tanzania | OTHER |
| Kibongoto National Tuberculosis Hospital, Tanzania | UNKNOWN |
| GlaxoSmithKline | INDUSTRY |
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The purpose of this study is twofold: (1) to assess the feasibility and safety of fixed dose combination zidovudine/lamivudine/abacavir in HIV infected subjects with tuberculosis in a resource-limited setting, and (2) to assess the impact of delayed versus early initiation strategies for fixed dose combination zidovudine/lamivudine/abacavir on the rate of tuberculosis-associated immune reconstitution inflammatory syndromes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early | Experimental | Initiation of fixed dose combination zidovudine/lamivudine/abacavir 2 weeks after commencing antituberculous therapy |
|
| Delayed | Experimental | Initiation of fixed dose combination zidovudine/lamivudine/abacavir 8 weeks after commencing antituberculous therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fixed dose combination zidovudine/lamivudine/abacavir | Drug | All subjects will receive fixed dose combination zidovudine(300 mg) / lamivudine (150 mg) / abacavir (300 mg) by mouth twice daily. Medications will be provided as long as deemed beneficial by the site investigator and study subject for up to two years. Toxicity substitutions are allowed per protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Serious Adverse Events (SAEs) | Feasibility and safety of fixed dose combination zidovudine/lamivudine/abacavir in HIV-infected subjects with tuberculosis in a resource-limited setting as assessed by the number of serious adverse events. Serious adverse events included any untoward medical occurrence that resulted in death, was considered life-threatening, required inpatient hospitalization or prolongation of existing hospitalization beyond what was required in the study, or resulted in persistent or resulted in significant disability/incapacity. | 104 weeks |
| Tuberculosis-immune Reconstitution Inflammatory Syndrome Events | Tuberculosis-immune reconstitution inflammatory syndrome was defined by the protocol as: a) new persistent fevers (temperature >101.5 degrees Fahrenheit) developing after the initiation of antiretroviral therapy, and not believed to be associated with antiretroviral therapy and without an identifiable source, b) marked worsening or emergence of intrathoracic lymphadenopathy, pulmonary infiltrates or pleural effusions on radiologic examination, or c) worsening or emergence of lymphadenopathy on serial examinations or worsening of other tuberculous lesions. | 104 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma HIV Ribonucleic Acid (RNA) Level < 400 Copies/ml | The number of subjects with plasma HIV RNA level <400 copies/ml. | 104 Weeks |
| HIV RNA Level < 50 Copies/ml | The number of subjects with plasma HIV RNA level <50 copies/ml. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathan M Thielman, MD, MPH | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kilimanjaro Christian Medical Centre | Moshi | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20001518 | Result | Shao HJ, Crump JA, Ramadhani HO, Uiso LO, Ole-Nguyaine S, Moon AM, Kiwera RA, Woods CW, Shao JF, Bartlett JA, Thielman NM. Early versus delayed fixed dose combination abacavir/lamivudine/zidovudine in patients with HIV and tuberculosis in Tanzania. AIDS Res Hum Retroviruses. 2009 Dec;25(12):1277-85. doi: 10.1089/aid.2009.0100. |
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Enrollment began in June 2004 and was completed in September 2005. Patients were enrolled at one of two hospitals in the Kilimanjaro Region of Tanzania.
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| ID | Title | Description |
|---|---|---|
| FG000 | Early | Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy |
| FG001 | Delayed | Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Early | Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy |
| BG001 | Delayed |
| 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 | Number of Serious Adverse Events (SAEs) | Feasibility and safety of fixed dose combination zidovudine/lamivudine/abacavir in HIV-infected subjects with tuberculosis in a resource-limited setting as assessed by the number of serious adverse events. Serious adverse events included any untoward medical occurrence that resulted in death, was considered life-threatening, required inpatient hospitalization or prolongation of existing hospitalization beyond what was required in the study, or resulted in persistent or resulted in significant disability/incapacity. | Intention to treat. | Posted | Number | Events | 104 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 | Early | Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute intestinal obstruction | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nathan Thielman | Duke University Medical Center | 919-6687174 | n.thielman@duke.edu |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D019259 | Lamivudine |
| C106538 | abacavir |
| C418262 | abacavir, lamivudine, and zidovudine drug combination |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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|
|
| 104 Weeks |
Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Delayed | Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy |
|
|
| Primary | Tuberculosis-immune Reconstitution Inflammatory Syndrome Events | Tuberculosis-immune reconstitution inflammatory syndrome was defined by the protocol as: a) new persistent fevers (temperature >101.5 degrees Fahrenheit) developing after the initiation of antiretroviral therapy, and not believed to be associated with antiretroviral therapy and without an identifiable source, b) marked worsening or emergence of intrathoracic lymphadenopathy, pulmonary infiltrates or pleural effusions on radiologic examination, or c) worsening or emergence of lymphadenopathy on serial examinations or worsening of other tuberculous lesions. | Intention to treat. | Posted | Number | Events | 104 weeks |
|
|
|
| Secondary | Plasma HIV Ribonucleic Acid (RNA) Level < 400 Copies/ml | The number of subjects with plasma HIV RNA level <400 copies/ml. | Intention to Treat Analysis, missing = failure. | Posted | Number | Participants | 104 Weeks |
|
|
|
| Secondary | HIV RNA Level < 50 Copies/ml | The number of subjects with plasma HIV RNA level <50 copies/ml. | Intent to Treat, missing = failure. | Posted | Number | Participants | 104 Weeks |
|
|
|
| 12 |
| 35 |
| 0 |
| 35 |
| EG001 | Delayed | Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy | 7 | 35 | 0 | 35 |
| Allergic reaction to suphalene-pyrimethamine | Immune system disorders |
|
| Amebiasis | Infections and infestations |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Cryptococcal meningitis | Infections and infestations |
|
| Disseminated kaposi's sarcoma | Skin and subcutaneous tissue disorders |
|
| Esophageal variceal bleeding | Gastrointestinal disorders |
|
| Head trauma, grand mal seizure | Nervous system disorders |
|
| Malaria | Infections and infestations |
|
| Mycobacteremia with M. sherrisii | Infections and infestations |
|
| Suspected abacavir hypersensitivity reaction | Immune system disorders |
|
| Syphilis | Infections and infestations |
|
| Tension pneumothorax | Respiratory, thoracic and mediastinal disorders |
|
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |