A Pilot Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multicenter Trial to Evaluate the Effect of Ranitidine on Immunologic Indicators in Asymptomatic HIV-1 Infected Subjects With a CD4 Cell Count Between 400-700 Cells/mm3

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: HIV Infections

Treatments: Drug: Ranitidine hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002106

135A

RAN-809

Details and patient eligibility

About

To evaluate the effect of ranitidine on immunologic indicators in asymptomatic HIV-1 infected patients with CD4 counts of 400-700 cells/mm3.

Full description

Patients are randomized to receive either ranitidine or matching placebo bid for 16 weeks, with follow-up every 4 weeks through week 20.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Patients must have:

• Asymptomatic HIV-1 infection.
• CD4 count of 400-700 cells/mm3.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Significant illness.
• Acute illness at randomization.
• Hemodialysis.

Prior Medication:

Excluded:

• Antiretroviral use within 60 days prior to study entry.