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NCT00000881
A Study of Cidofovir in HIV-Infected Children With Cytomegalovirus (CMV) Disease
Phase 1 trial testing Cidofovir in Cytomegalovirus Infections. Withdrawn.
Quick facts
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Primary purpose | treatment |
Drugs / interventions tested
- Cidofovir (CIDOFOVIR) — full drug profile →
- Probenecid (probenecid) — full drug profile →
Conditions studied
- Cytomegalovirus Infections — all drugs for Cytomegalovirus Infections →
- Cytomegalovirus Retinitis — all drugs for Cytomegalovirus Retinitis →
- HIV Infections — all drugs for HIV Infections →
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Who can join
Adults 3 Months to 13, any sex, with Cytomegalovirus Infections or Cytomegalovirus Retinitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Part A: To determine the safety and pharmacokinetics of sequential single doses of cidofovir in HIV-infected children with end-organ cytomegalovirus (CMV) disease. Part B: To determine the safety (including time to progression of CMV retinitis by retinal exam), pharmacokinetics, and long-term (6 months) tolerance of multiple-dose cidofovir in HIV-infected children with CMV retinitis. Part B: To determine the effect of multiple-dose cidofovir on the virologic parameters of CMV retinitis (viral load, shedding, and resistance to antiviral agents). \[AS PER AMENDMENT 1/7/98: To determine the safety, tolerance and pharmacokinetics of sequential single doses of cidofovir in HIV-infected children with CMV retinitis. To determine the safety (including time to progression of CMV retinitis by retinal exam), pharmacokinetics, and long-term (6-month) tolerance of multiple doses of cidofovir in HIV-infected children with CMV retinitis.\] While the intravenous formulation of cidofovir has been approved for the treatment of CMV retinitis in HIV-infected individuals, information is limited regarding its safety and tolerance in HIV-infected children. Intravenous cidofovir requires less frequent administration for both induction and maintenance therapy of CMV retinitis than other currently available therapies. If found to be safe and well tolerated in HIV-infected children with CMV retinitis, intravenous cidofovir would add significantly to agents available to treat this debilitating opportunistic infection.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT00000881
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
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Other recruiting trials for Cytomegalovirus Infections
Currently open trials in the same condition.
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- NCT06694428 — Evaluation of Software for Interpreting Virological Results Indicated for the Diagnosis of Cytomegalovirus (CMV) Infecti · recruiting
- NCT06812598 — Efficacy of Extended Letermovir Prophylaxis to Prevent CMV Reactivation in High-Risk Chinese Adults Undergoing Allogenei · NA · recruiting
- NCT06554197 — Evaluation of CMV/EBV-CMI in Haploid HSCT · recruiting
Other National Institute of Allergy and Infectious Diseases (NIAID) trials
Trials by the same sponsor.
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- NCT07124559 — A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of · Phase 1, PHASE2 · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00000881 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
- Last refreshed: 29 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00000881.
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