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

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Ranitidine hydrochloride	Phase II

Further Study Details: 

Expected Total Enrollment:  104

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

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

California
      Pacific Oaks Med Group, Sherman Oaks,  California,  91403,  United States
Florida
      Community Research Initiative, Coral Gables,  Florida,  33146,  United States
North Carolina
      Duke Univ Med Ctr, Durham,  North Carolina,  27710,  United States
Texas
      Houston Clinical Research Network, Houston,  Texas,  77006,  United States

Study ID Numbers:  135A; RAN-809
Record last reviewed:  May 1994
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002106
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08