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

HIV Infections Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000765
• Other study ID #: DATRI 002
• Secondary ID: 11733
• Status: Completed
• Phase: N/A
• Est. completion date: June 2002

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Infections

Intervention

Drug:
• Zidovudine

Locations

Country	Name	City	State
United States	Johns Hopkins Univ School of Medicine	Baltimore	Maryland
United States	Univ of Illinois	Chicago	Illinois
United States	Univ of Texas Southwestern Med Ctr of Dallas	Dallas	Texas
United States	Broward Gen Med Ctr	Fort Lauderdale	Florida
United States	Houston Clinical Research Network	Houston	Texas
United States	Cedars Sinai Med Ctr	Los Angeles	California
United States	Bellevue Hosp / New York Univ Med Ctr	New York	New York
United States	Palo Alto Veterans Administration Med Ctr	Palo Alto	California
United States	Miriam Hosp / Brown Univ	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Glaxo Wellcome

Country where clinical trial is conducted

United States, 

References & Publications (1)

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)