An Open Trial Combining Zidovudine, Interferon-alfa, and Recombinant CD4-IgG With Transplantation of Syngeneic Bone Marrow and Peripheral Blood Lymphocytes From Healthy gp160-Immunized Donors in the Treatment of Patients With HIV Infection

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00000647
• Date of registration: 02/11/1999
• Primary sponsor: National Institute of Allergy and Infectious Disease (NIAID)
• Public title: An Open Trial Combining Zidovudine, Interferon-alfa, and Recombinant CD4-IgG With Transplantation of Syngeneic Bone Marrow and Peripheral Blood Lymphocytes From Healthy gp160-Immunized Donors in the Treatment of Patients With HIV Infection
• Scientific title: An Open Trial Combining Zidovudine, Interferon-alfa, and Recombinant CD4-IgG With Transplantation of Syngeneic Bone Marrow and Peripheral Blood Lymphocytes From Healthy gp160-Immunized Donors in the Treatment of Patients With HIV Infection
• Date of first enrolment: July 2000
• Target sample size: 6
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00000647
• Study type: Interventional
• Study design: Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: KM Zunich

Key inclusion & exclusion criteria

Inclusion Criteria

- Each patient must have an identical twin in a normal state of health with a normal
screening lab panel and a normal immune profile who is documented to be antibody and
culture and polymerase chain reaction (PCR) negative for HIV.

- Ability to provide informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

- Malignancy other than Kaposi's sarcoma.

Patients with the following are excluded:

- Unwillingness to comply with current NIH Clinical Center guidelines concerning
appropriate notification of all current sexual partners of an individual regarding
his or her positive HIV serostatus and the risk of transmission of HIV infection.

- Presence of a serious opportunistic infection or other illness or condition that, in
the opinion of the principal investigator, warrants exclusion from participation in
the study.

Current use of illicit drugs or significant amounts of alcohol that, in the opinion of the
principal investigator, would interfere with compliance with the study.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: CD4-IgG

Drug: Interferon alfa-n1

Drug: Zidovudine

Procedure: Bone marrow transplant

Procedure: Peripheral lymphocyte infusion

Secondary ID(s)

11723

90 I-0076

IRP 011

NIAID 90 CC-IRP011

Source(s) of Monetary Support

Please refer to primary and secondary sponsors