Trial · NCT04648280
Safety and Pharmacokinetics Evaluation of Fostemsavir + (OBT) in HIV-1 Infected Children and Adolescents Who Are Failing Their cART and Have Dual- or Triple-class Antiretroviral Resistance
NCT04648280, Phase 1, Phase 2, Active not recruiting, PENTA Foundation
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Pharmacokinetics Evaluation of Fostemsavir + (OBT) in HIV-1 Infected Children and Adolescents Who Are Failing Their cART and Have Dual- or Triple-class Antiretroviral Resistance. Trials, record NCT04648280. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04648280
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Pharmacokinetics Evaluation of Fostemsavir + (OBT) in HIV-1 Infected Children and Adolescents Who Are Failing Their cART and Have Dual- or Triple-class Antiretroviral Resistance
- NCT number
- NCT04648280
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 60 participants, estimated
- Lead sponsor
- PENTA Foundation
- Conditions
- HIV Infections With Multi Drug Resistant Virus
- Interventions
- Fostemsavir
- First posted
- 2020-12-01
- Last updated
- 2026-03-05
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Occurrence of the following events through Week 24 | 24 weeks | |
| Primary | AUC(0-tau) | at week 1, 4, 12, 24, 48 | |
| Primary | Cmax | at week 1, 4, 12, 24, 48 | |
| Primary | Ctau of temsavir across weight bands | at week 1, 4, 12, 24, 48 | |
| Secondary | Proportion of patients with HIV-1 RNA <50 copies/mL | at 24 weeks and 48 weeks | To evaluate the antiviral activity of fostemsavir + OBT |
| Secondary | Change in log10 HIV-1 RNA from baseline | at 24 weeks and 48 weeks | |
| Secondary | Occurrence of: AEs, treatment-related AEs, AEs of Grade 3 or higher, serious AEs, and AEs leading to premature study treatment discontinuation. | at Week 48 and at the end of Study | |
| Secondary | Occurrence of WHO 3 or 4 defining events, or death | up to 156 weeks | |
| Secondary | efficacy of fostemsavir plus OBT | up to 156 weeks | changes from baseline in CD4+ T cell counts and the percentage of CD4 + T-cells |
| Secondary | Emergence of genotypic or phenotypic resistance to Temsavir and components of OBT | up to 156 weeks |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41735855 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04648280
GET https://conductscience.org/api/trials/v1/NCT04648280/registered