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The primary objectives of this trial are to provide FTC-203 study participants in South Africa with continued access to the study drug, emtricitabine (FTC), following completion of the FTC-203 study and to collect long-term safety information in participants receiving emtricitabine in combination with other antiretroviral agents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emtricitabine | Experimental | Participants will receive emtricitabine for as long as they continue to meet specific virologic criteria and until either: (1) the participant chooses to discontinue treatment of emtricitabine and withdraw from the rollover protocol; (2) the participant experiences a toxicity that necessitates the permanent discontinuation of emtricitabine, or (3) emtricitabine is approved for market distribution in the participant's country of residence. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emtricitabine | Drug | 6 mg/kg capsule once daily, up to a maximum dose of 200 mg once daily, or 10 mg/mL oral solution once daily, up to a maximum of 240 mg once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had Access to, and Received the Intervention | This endpoint has been included to satisfy the requirements of ClinicalTrials.gov. However, there were no prespecified endpoints in this study. | Up to 586 weeks |
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Key Inclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Themba Lethu Clinic, Helen Joseph Hospital, Westdene | Johannesburg | South Africa | ||||
| Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital |
59 participants were screened.
Participants were enrolled at 2 study sites in South Africa. The first participant was screened on 22 November 2005. The last study visit occurred on 13 February 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Emtricitabine | Emtricitabine (FTC) 6 mg/kg capsule once daily, up to a maximum of 200 mg once daily, or 10 mg/mL oral solution once daily, up to a maximum of 240 mg once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set: all enrolled participants who have received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Emtricitabine | Emtricitabine 6 mg/kg capsule once daily, up to a maximum of 200 mg once daily, or 10 mg/mL oral solution once daily, up to a maximum of 240 mg once daily |
| 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 Who Had Access to, and Received the Intervention | This endpoint has been included to satisfy the requirements of ClinicalTrials.gov. However, there were no prespecified endpoints in this study. | Participants who were enrolled into the study and received study drug. | Posted | Count of Participants | Participants | Up to 586 weeks |
|
|
Up to 586 Weeks + 30 days
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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 | Emtricitabine | Emtricitabine 6 mg/kg capsule once daily, up to a maximum of 200 mg once daily, or 10 mg/mL oral solution once daily, up to a maximum of 240 mg once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Essential hypertension | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosures & Data Transparency | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 14, 2017 | Jan 15, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment | Jul 24, 2013 | Jan 15, 2018 | Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: Original | Jan 24, 2005 | Jan 22, 2018 | Prot_002.pdf |
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| ID | Term |
|---|---|
| D000068679 | Emtricitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| Soweto |
| South Africa |
| Protocol Violation |
|
| Virologic failure |
|
| Pregnancy |
|
| Rolled over to other Gilead Study |
|
| Participant Relocated |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Participants |
|
|
| 0 |
| 50 |
| 13 |
| 50 |
| 0 |
| 50 |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Abortion incomplete | Pregnancy, puerperium and perinatal conditions | MedDRA 20.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Attention deficit/hyperactivity disorder | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| Conduct disorder | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
|
| Reactive attachment disorder of infancy or early childhood | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| Breast enlargement | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Post procedural sepsis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |