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Rollover Study Protocol for Pediatric Patients in South Africa for Continued Access to Emtricitabine
Phase 2 trial testing Emtricitabine in HIV-1 Infection in 50 participants. Completed in 13 February 2017.
| Lead sponsor | Gilead Sciences |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 50 |
| Start date | 22 November 2005 |
| Primary completion | 13 February 2017 |
| Estimated completion | 13 February 2017 |
| Sites | 2 locations across South Africa |
Gilead Sciences — full company profile →
Adults 1 Month to 17, any sex, with HIV-1 Infection. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
This endpoint has been included to satisfy the requirements of ClinicalTrials.gov. However, there were no prespecified endpoints in this study.
| Group | Value | 95% CI |
|---|---|---|
| Emtricitabine | 50 |
Time frame: Up to 586 Weeks + 30 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Emtricitabine |
|---|---|---|
| Lower limb fracture | Injury, poisoning and procedural complications | — |
| Appendicitis | Infections and infestations | — |
| Essential hypertension | Vascular disorders | — |
| Femur fracture | Injury, poisoning and procedural complications | — |
| Hand fracture | Injury, poisoning and procedural complications | — |
| Overdose | Injury, poisoning and procedural complications | — |
| Weight decreased | Investigations | — |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Neutropenia | Blood and lymphatic system disorders | — |
| Headache | Nervous system disorders | — |
| Abortion incomplete | Pregnancy, puerperium and perinatal conditions | — |
| Pyrexia | General disorders | — |
| Swelling | General disorders | — |
| Attention deficit/hyperactivity disorder | Psychiatric disorders | — |
| Conduct disorder | Psychiatric disorders | — |
| Reactive attachment disorder of infancy or early childhood | Psychiatric disorders | — |
| Breast enlargement | Reproductive system and breast disorders | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — |
| Pneumonia | Infections and infestations | — |
| Post procedural sepsis | Infections and infestations | — |
Most-reported serious reactions: Lower limb fracture, Appendicitis, Essential hypertension, Femur fracture, Hand fracture, Overdose, Weight decreased, Bronchospasm.
Data from ClinicalTrials.gov NCT00743340 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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