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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000765

Collaborator

Glaxo Wellcome (Industry)

Enrollment

Locations

8.9

Patients Per Site

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Zidovudine	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Intervention Model:

Parallel Assignment

Primary Purpose:

Treatment

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)

Actual Study Completion Date :

Jun 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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.
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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Johns Hopkins Univ School of Medicine	Baltimore	Maryland	United States	212872080
6	Bellevue Hosp / New York Univ Med Ctr	New York	New York	United States	10016
7	Miriam Hosp / Brown Univ	Providence	Rhode Island	United States	02906
8	Univ of Texas Southwestern Med Ctr of Dallas	Dallas	Texas	United States	75235
9	Houston Clinical Research Network	Houston	Texas	United States	77006