Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00001027 · ClinicalTrials.gov registry record · Phase 1
A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole
A Phase 1 study of HIV Infections and Pneumonia, Pneumocystis Carinii, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 13
- Study locations
NCT00001027: Completed Phase 1 study of HIV Infections and Pneumonia, Pneumocystis Carinii, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00001027 is a Phase 1 study of HIV Infections and Pneumonia, Pneumocystis Carinii that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 32 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (93% lower). The trial reports 13 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001027, a Phase 1 study of HIV Infections and Pneumonia, Pneumocystis Carinii, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 13
- Study locations
Study Summary
Primary: To compare the pharmacokinetics of biweekly and monthly dose regimens of intravenous pentamidine in HIV-infected infants and children who require PCP prophylaxis and who are intolerant to oral trimethoprim - sulfamethoxazole. To determine the safety and tolerance of these regimens in this patient population. Secondary: To obtain information on the rate of PCP breakthrough in infants and children receiving parenteral pentamidine prophylaxis. Prophylaxis against Pneumocystis carinii pneumonia is recommended for all HIV-infected children considered to be at high risk. In children younger than 5 years of age with intolerance to trimethoprim - sulfamethoxazole, parenteral pentamidine may be a successful alternative.
Conditions Studied
Interventions
- DRUG Pentamidine isethionate
Study Locations (13)
California
- Usc La Nichd Crs - Los Angeles
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS - Los Angeles
- Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. - Oakland
New York
- NYU Med. Ctr., Dept. of Medicine - New York
- Harlem Hosp. Ctr. NY NICHD CRS - New York
- SUNY Upstate Med. Univ., Dept. of Peds - Syracuse
District of Columbia
- Children's National Med. Ctr., ACTU - Washington D.C.
- Howard Univ. Washington DC NICHD CRS - Washington D.C.
Illinois
- Chicago Children's CRS - Chicago
- Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease - Chicago
Other
- San Juan City Hosp. PR NICHD CRS - San Juan
- Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS - San Juan
Louisiana
- Tulane/LSU Maternal/Child CRS - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Est. Completion | 1996-09 |
| Phase | Phase 1 |
What the finished NCT00001027 record still lists
NCT00001027 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which Pentamidine isethionate is the first listed.
NCT00001027 lists 13 locations in 6 states (California, New York, District of Columbia).
Frequently Asked Questions
What is clinical trial NCT00001027 about?
NCT00001027 is a clinical study titled "A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole". Primary: To compare the pharmacokinetics of biweekly and monthly dose regimens of intravenous pentamidine in HIV-infected infants and children who require PCP prophylaxis and who are intolerant to oral trimethoprim - sulfamethoxazole. To determine the safety and tolerance of these regimens in this p...
What is the current status of trial NCT00001027?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. Estimated completion is 1996-09.
What conditions does trial NCT00001027 study?
This clinical trial studies the following conditions: HIV Infections, Pneumonia, Pneumocystis Carinii.
What interventions are being tested in trial NCT00001027?
The interventions under investigation include: Pentamidine isethionate (DRUG).
Who is sponsoring clinical trial NCT00001027?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001027 being conducted?
This trial has 13 study locations across California, District of Columbia, Illinois, Louisiana, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00001027's enrollment target sits among peer trials
32 421st of 542 higher than 119 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
CAR-T Cells for HIV Infection
RECRUITING · Phase 1
-
A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV
RECRUITING · Phase 1
-
Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Adult Participants Who Previously Participated in HVTN 706
RECRUITING · Phase 1
-
Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics
RECRUITING · Phase 1
-
A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
RECRUITING · Phase 1
-
First Time in Human Study of Long Acting VH4524184 Formulations
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02445781 · 32 participants · Early Phase 1
Differing Levels of Hypoglycemia
- NCT02792270 · 32 participants · NA
Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT
- NCT03068910 · 32 participants · Early Phase 1
Hyperandrogenemia and Altered Day-night LH Pulse Patterns
- NCT03208868 · 32 participants · NA
Leucine Enriched Essential Amino Acid Mixture to Reverse Muscle Loss in Cirrhosis