Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Glaxo Wellcome

Conditions:

HIV Infections

Eligibility:

All Genders

13+ years

Phase:

NA

Brief 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 vi...

Detailed 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 th...

Eligibility 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).

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

June 1 2002

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT00000765

End Date

June 1 2002

Last Update

October 28 2021

Active Locations (9)

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Page 1 of 3 (9 locations)

1

Cedars Sinai Med Ctr

Los Angeles, California, United States, 90048

2

Palo Alto Veterans Administration Med Ctr

Palo Alto, California, United States, 94304

3

Broward Gen Med Ctr

Fort Lauderdale, Florida, United States, 33316

4

Univ of Illinois

Chicago, Illinois, United States, 60612

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