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

This study has been completed.
Sponsor:
Collaborator:
Glaxo Wellcome
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000765
First received: November 2, 1999
Last updated: March 15, 2012
Last verified: March 2012

November 2, 1999
March 15, 2012
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Complete list of historical versions of study NCT00000765 on ClinicalTrials.gov Archive Site
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Pilot Study to Evaluate the Efficacy of Zidovudine in Preventing CD4+ Lymphocyte Decline in Patients With Primary HIV Infection. (One Treatment Arm Receives Placebo)
Pilot Study to Evaluate the Efficacy of Zidovudine in Preventing CD4+ Lymphocyte Decline in Patients With Primary HIV Infection. (One Treatment Arm Receives Placebo)

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
HIV Infections
Drug: Zidovudine
Not Provided
Holodniy M, Niu M, Bethel J, Standiford H, Schnittman S. A pilot study to evaluate the efficacy of zidovudine (ZDV) versus placebo in primary HIV infection (DATRI 002): a preliminary analysis. Int Conf AIDS. 1996 Jul 7-12;11(Program Supplement):26 (abstract no LBB6022)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
June 2002
Not Provided

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).
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000765
DATRI 002, 11733
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Glaxo Wellcome
Study Chair: M Niu
Study Chair: H Standiford
National Institute of Allergy and Infectious Diseases (NIAID)
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP