Overview

Pilot Study to Evaluate the Efficacy of Zidovudine in Preventing CD4+ Lymphocyte Decline in Patients With Primary HIV Infection. (One Treatment Arm Receives Placebo)

Status:
Completed
Trial end date:
2002-06-01
Target enrollment:
0
Participant gender:
All
Summary
To evaluate the safety and efficacy of early treatment with zidovudine for preventing a decline in CD4+ lymphocyte counts in patients with primary HIV infection. To determine the natural history of virologic and immunologic changes in primary HIV infection. Previous studies indicate that intervention with zidovudine during primary HIV infection could reduce the initial viral burden and subsequent decline in immune functions, and could prolong not only the time to development of AIDS but also the time to initiation of chronic antiretroviral therapy.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:
Glaxo Wellcome
Treatments:
Zidovudine
Criteria
Inclusion Criteria

Concurrent Medication:

Allowed:

- Medications for nausea, vomiting, analgesia, or anxiety.

Patients must have:

- Asymptomatic or symptomatic primary HIV infection, plus one of the following two
criteria:

1. p24 antigenemia documented within 1 month prior to study entry and either HIV
enzyme immunoassay (IA) negative or HIV IA positive with Western blot
negative/indeterminate, within 1 month prior to study entry.

2. Documented seroconversion within 1 month prior to study entry and Western blot
negative/indeterminate.

- Consent of parent or guardian if less than 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following condition are excluded:

- poor venous access.

Concurrent Medication:

Excluded:

- Chronic steroid use.

- Immunomodulators.

- Myelosuppressive agents.

- Other antiretroviral agents or experimental therapies (NOTE: FDA-approved therapies
permitted in patients who qualify after week 24; experimental therapies permitted
after study week 48).