CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed
Drug / intervention
Pentamidine isethionate +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00000991
NCT00000991Phase 3Completed

A Randomized Trial of Three Anti-Pneumocystis Agents Plus Zidovudine for the Primary Prevention of Serious Infections in Patients With Advanced HIV Infection

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Aug 31, 2001·Updated Nov 4, 2021

In Brief

A Phase 3 clinical trial evaluating Pentamidine isethionate, Sulfamethoxazole-Trimethoprim, and 2 other interventions for Pneumonia, Pneumocystis Carinii and HIV Infections. Completed, across 21 sites in 2 countries.

Detailed Summary

To evaluate and compare 3 anti-pneumocystis regimens plus zidovudine (AZT) in persons with HIV infection and T4 cell count less than 200 cells/mm3. All persons completing at least 8 weeks of therapy on 081 will be offered the opportunity to participate in the nested study (ACTG 981) of systemic antifungal therapy (fluconazole) versus local therapy (Clotrimazole) for the prevention of serious fungal disease. Persons with HIV disease who are receiving AZT are at risk for PCP, toxoplasmosis, bacterial pneumonia, and other serious infections. It is therefore important to find drugs that can be given along with AZT to control these infections. Aerosolized pentamidine (PEN) has been shown to be useful in preventing PCP and is expected to lower the 2-year risk of PCP. Both sulfamethoxazole/trimethoprim (SMX/TMP) and dapsone probably also provide effective preventive treatment against PCP, and both may be useful in preventing toxoplasmosis and extrapulmonary pneumocystosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTanzania, United States
Collaborators--

Timeline

Phase 3CompletedFinished
1994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 31, 2001
Study CompletionApr 1, 1994
TodayJul 2, 2026
Posted 24.8 years ago

Interventions

Pentamidine isethionatedrug

Sulfamethoxazole-Trimethoprimdrug

Dapsonedrug

Zidovudinedrug