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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)

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Zidovudine (Drug)

Phase: N/A

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
M Niu, Study Chair
H Standiford, Study Chair

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.

Clinical Details

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

Study design: Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

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 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.

Eligibility

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

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).

Locations and Contacts

Cedars Sinai Med Ctr, Los Angeles, California 90048, United States

Palo Alto Veterans Administration Med Ctr, Palo Alto, California 94304, United States

Broward Gen Med Ctr, Fort Lauderdale, Florida 33316, United States

Univ of Illinois, Chicago, Illinois 60612, United States

Johns Hopkins Univ School of Medicine, Baltimore, Maryland 212872080, United States

Bellevue Hosp / New York Univ Med Ctr, New York, New York 10016, United States

Miriam Hosp / Brown Univ, Providence, Rhode Island 02906, United States

Univ of Texas Southwestern Med Ctr of Dallas, Dallas, Texas 75235, United States

Houston Clinical Research Network, Houston, Texas 77006, United States

Additional Information

Click here for more information about Zidovudine

Related publications:

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)


Last updated: March 15, 2012

Page last updated: August 23, 2015

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