|
|
|
|
|
|
Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000991 |
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.
Condition | Intervention | Phase |
Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Pentamidine isethionate Drug: Sulfamethoxazole-Trimethoprim Drug: Dapsone Drug: Zidovudine |
Phase III |
MedlinePlus related topics: | AIDS Pneumonia Toxoplasmosis |
Drug Information available for: | Zidovudine Sulfamethoxazole Trimethoprim Trimethoprim-sulfamethoxazole combination Dapsone Pentamidine |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Randomized Trial of Three Anti-Pneumocystis Agents Plus Zidovudine for the Primary Prevention of Serious Infections in Patients With Advanced HIV Infection |
Estimated Enrollment: | 600 |
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.
All patients receive AZT. In addition, they are placed in one of three groups to receive either SMX/TMP, dapsone, or PEN. Stratification criteria are:
Received first AZT equal to or less than 6 weeks prior to study entry. Received first AZT more than 6 weeks prior to study entry. Potential to participate in ACTG 981. ACTG center in which the patient is enrolled.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patient must conform to the following:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded within 4 weeks of study entry:
Show 40 Study Locations |
Study Chair: | S Bozzette | |
Study Chair: | S Spector |
Study ID Numbers: | ACTG 081 |
First Received: | November 2, 1999 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00000991 |
Health Authority: | United States: Federal Government |
|
|
|
|
|
|