To provide oral ganciclovir to patients who require maintenance for control of cytomegalovirus (CMV) retinitis, but who lack patent permanent central venous access for long-term administration of intravenous drugs.

Condition	Treatment or Intervention
Cytomegalovirus Retinitis HIV Infections	Drug: Ganciclovir

Further Study Details: 

Patients receive oral ganciclovir as maintenance. Patients enrolled at time of closure of enrollment will receive 2 months of study drug and undergo follow-up.

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Patients must have:

• AIDS.
• Stable CMV retinitis.
• Treatment with IV ganciclovir or IV foscarnet for at least 18 of the past 21 days.
• No permanent central IV catheter at present.
• Had a permanent central IV catheter removed two or more times within the past 6 months due to catheter infection or thrombosis.
• Consent of guardian if less than legal age of consent.

Exclusion Criteria

Co-existing Condition: Patients with the following symptoms or conditions are excluded:

• Require continuation of concomitant medications precluded by this protocol. Concurrent Medication: Excluded:
• Intravitreal anti-CMV treatment.
• Any other concomitant medications precluded by the protocol. Patients with the following prior condition are excluded: History of hypersensitivity to acyclovir or ganciclovir.

California
      Roche Global Development - Palo Alto, Palo Alto,  California,  94303,  United States

Study ID Numbers:  037C; GANS2224
Record last reviewed:  November 1995
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002135
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08