A Study of Zidovudine Plus Interleukin-2 in HIV-Infected Patients Who Have No Symptoms of Infection But Who Have Tender Lymph Nodes

• Register: ClinicalTrials.gov
• Last refreshed on: 8 November 2021
• Main ID: NCT00001005
• Date of registration: 02/11/1999
• Prospective Registration: No
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: A Study of Zidovudine Plus Interleukin-2 in HIV-Infected Patients Who Have No Symptoms of Infection But Who Have Tender Lymph Nodes
• Scientific title: Interleukin-2 Augmentation of Specific Anti-HIV Immune Responses: Phase I Trial of the Combination of 3'-Azido-3'-Deoxythymidine (Zidovudine) and Recombinant Interleukin-2 in Patients With Asymptomatic HIV Infection Associated With Lymphadenopathy (Walter Reed Stage II)
• Date of first enrolment: February 1998
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00001005
• Study type: Interventional
• Study design: Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: K Weinhold

Key inclusion & exclusion criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

- Necessary topical agents, including nystatin or clotrimazole, as well as acyclovir.
Patients on medications without which the patient would be placed at significant risk
(seizures, diabetic control, respiratory embarrassment) may continue only at the
discretion of the study pharmacologist.

Patients must have:

- Asymptomatic HIV infection associated with lymphadenopathy.

- Walter Reed Stage II disease, with positive antibody to HIV confirmed by Western blot
test.

Exclusion Criteria

Co-existing Condition:

Patients will be excluded from the study for the following:

- Development of a disease requiring a drug which might potentiate toxicity of the study
drugs or a drug likely to have antiretroviral effect.

- Active opportunistic infection.

- Major organ allograft.

- Significant cardiac or pulmonary disease or central nervous system (CNS) lesions.

Concurrent Medication:

Excluded:

- Ongoing therapy for an opportunistic infection.

- Beta-blockers.

- Antihypertensive medication other than diuretics.

- All nonessential medication including pain medications.

Patients without interleukin 2 (IL-2) augmentable anti-HIV antibody-dependent cellular
cytotoxicity (ADCC) or or cell-mediated cytotoxicity (CMC) in vitro are excluded.

Prior Medication:

Excluded within 12 weeks of study entry:

- Other antiretroviral agents (patients with CD4 counts of 400 - 500 per mm3 who are
receiving AZT may continue to receive it until study treatment is initiated).

- Immunomodulators.

- Corticosteroids.

- Other experimental therapy.

- Antineoplastic chemotherapy.

Active drug or alcohol abuse.



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

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: Zidovudine

Drug: Aldesleukin

Secondary ID(s)

ACTG 042

11017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors