A Phase I, Dose-Escalating Safety and Tolerance Study of sCD4-PE40 in HIV-Infected Persons

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00000743
• Date of registration: 02/11/1999
• Primary sponsor: National Institute of Allergy and Infectious Disease (NIAID)
• Public title: A Phase I, Dose-Escalating Safety and Tolerance Study of sCD4-PE40 in HIV-Infected Persons
• Scientific title: A Phase I, Dose-Escalating Safety and Tolerance Study of sCD4-PE40 in HIV-Infected Persons
• Date of first enrolment: July 2000
• Target sample size: 64
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00000743
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: van der Horst C

Key inclusion & exclusion criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

- PCP prophylaxis with aerosolized pentamidine, trimethoprim / sulfamethoxazole, or
dapsone.

- Clotrimazole troches or nystatin oral suspension for oral candidiasis.

- Acyclovir (up to 1000 mg/day for 10 days) for herpes lesions.

- Erythropoietin.

Patients must have:

- Documented HIV infection by ELISA confirmed by a second method. If a prior diagnosis
of AIDS has not been established by CDC criteria, a confirmatory test is required.

- CD4 count = or < 300 cells/mm3 within 4 weeks prior to study entry.

- Positive p24 antigen.

Patients entering the AZT portion of the study only:

- Must be AZT naive or have had less than 2 months of AZT therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

- Hemophilia.

- Acute medical problems (including active opportunistic infections such as active
cryptococcosis, Pneumocystis carinii, herpes zoster, histoplasmosis, or CMV or
nonopportunistic diseases including liver disease, renal disease, or orthostatic
hypotension) at time of study entry.

- Active pulmonary disease.

- Chronic active hepatitis B surface antigenemia or unstable hepatitis C.

- Current diagnosis of malignancy for which systemic therapy would be required during
the study.

- Inadequate intravenous access.

Concurrent Medication:

Excluded:

- Hepatotoxic agents.

- Other antiretroviral or immunomodulator agents (including but not limited to AZT,
ddI, ddC, interferon, and steroids).

- Other investigational drugs.

- Systemic therapy for malignancy.

- G-CSF and GM-CSF.

Prior Medication:

Excluded:

- Other antiretroviral or immunomodulator agents (including but not limited to AZT,
ddI, ddC, interferon, and steroids) within 4 weeks prior to study entry.

- Ribavirin within 90 days prior to study entry.

- Cytotoxic chemotherapy within one month prior to study entry.

- Prior soluble CD4 or CD4-Ig.

Excluded in patients entering the AZT portion of the study:

- More than 2 months of prior AZT therapy.

Current active alcoholism or active substance abuse.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: Alvircept sudotox

Drug: Zidovudine

Secondary ID(s)

11177

ACTG 201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Glaxo Wellcome

Upjohn