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.
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 Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
105
Hennepin County Med Clinic
Minneapolis, Minnesota, United States
Univ of Minnesota
Minneapolis, Minnesota, United States
St Paul Ramsey Med Ctr
Saint Paul, Minnesota, United States
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
Univ of Texas Galveston
Galveston, Texas, United States
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