The Effectiveness of Two Anti-HIV Treatments in HIV-Infected Patients

Phase 2

Completed

• Conditions: HIV Infections

• Registration Number: NCT00001057
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

To determine the effects of zidovudine (AZT) alone and in combination with didanosine (ddI) on viral load in the lymphoid tissue and blood of antiretroviral-naive, HIV-infected patients with CD4 counts greater than or equal to 550 cells/mm3.

Recent studies have shown that during the asymptomatic phase (clinical latency) of HIV infection, there is an extraordinarily large number of infected CD4+ lymphocytes and macrophages throughout the lymphoid system, both in latent and productive states. These findings support the belief that early intervention therapy with reverse transcriptase inhibitors could prolong the clinical latency period.

Detailed Description

Recent studies have shown that during the asymptomatic phase (clinical latency) of HIV infection, there is an extraordinarily large number of infected CD4+ lymphocytes and macrophages throughout the lymphoid system, both in latent and productive states. These findings support the belief that early intervention therapy with reverse transcriptase inhibitors could prolong the clinical latency period.

Patients are randomized to receive AZT alone, AZT plus ddI, or no therapy (placebo) daily for 48 weeks. Patients are followed at weeks 2, 4, and 8, and then every 8 weeks thereafter until week 48.

Study Timeline

• Study Completion: 1995-05
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (7)

Univ of Nebraska Med Ctr; 🇺🇸 Omaha, Nebraska, United States

Case Western Reserve Univ; 🇺🇸 Cleveland, Ohio, United States

Thomas Jefferson Univ Hosp; 🇺🇸 Philadelphia, Pennsylvania, United States

St Paul Ramsey Med Ctr; 🇺🇸 Saint Paul, Minnesota, United States

Univ of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Univ of Texas Galveston; 🇺🇸 Galveston, Texas, United States

Hennepin County Med Clinic; 🇺🇸 Minneapolis, Minnesota, United States