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

National Institute of Allergy and Infectious Diseases (NIAID)

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Zidovudine

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT00000765

11733 (Registry Identifier)

DATRI 002

Details and patient eligibility

About

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.

Full description

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.

Patients are randomized to receive either zidovudine or placebo daily for 24 weeks. Patients are followed until development of an AIDS-related opportunistic infection or malignancy. After week 24, patients meeting standard prescribing criteria may start FDA-approved anti-HIV therapies. After study week 48, patients may co-enroll on another clinical trial to receive experimental therapy.

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).