A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months

Completed · Phase 3

Conditions studied: HIV Infections

In brief

To determine the clinical efficacy of indinavir sulfate or placebo in combination with zidovudine ( AZT ) and lamivudine ( 3TC ) in AIDS patients. Protease inhibitors such as indinavir sulfate may be effective in patients with advanced HIV disease who have received prior AZT therapy. Since studies suggest that triple drug therapy may have an advantage over both monotherapy and two drug therapy, the combination of indinavir sulfate with AZT and 3TC should be evaluated.

Key facts

Study ID

NCT00000841

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

1750

Expected to finish

1997-06-01

Last updated by the study team

2021-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Required:
• PCP prophylaxis.
• Allowed:
• Topical or oral antifungal agents (other than oral ketoconazole).
• Approved agents for opportunistic infections.
• Antibiotics unless specifically excluded.
• Systemic corticosteroids for no more than 21 days.
• Vitamins.
• Recombinant erythropoietin.
• G-CSF.
• Regularly prescribed medications such as allergy medications, antidepressants, antipyretics, analgesics, oral contraceptives, megestrol, and testosterone.
• Concurrent Treatment:
• Allowed:
• Acupuncture.
• Visualization techniques.
• Patients must have:
• HIV infection.
• CD4 count <= 200 cells/mm3.
• At least 6 months total prior AZT therapy.

You may not qualify if…

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Malignancy requiring systemic therapy other than minimal Kaposi's sarcoma.
• Concurrent Medication:
• Excluded:
• Antiretrovirals other than study drugs.
• Rifabutin and rifampin.
• Investigational drugs other than indinavir sulfate.
• Systemic cytotoxic chemotherapy.
• Oral ketoconazole.
• Chronic systemic corticosteroids.
• Herbal therapies.
• Patients with the following prior conditions are excluded:
• Unexplained temperature > 38.5 C for any 7 days within 30 days prior to study entry.
• Chronic diarrhea persisting for 15 days within 30 days prior to study entry.
• History of acute or chronic pancreatitis.
• Acute hepatitis within 30 days prior to study entry.
• Grade 2 or worse bilateral peripheral neuropathy within 60 days prior to study entry.
• Dose-limiting intolerance to prior AZT at 600 mg/day.
• Prior Medication:
• Excluded:
• More than 1 week of prior 3TC.
• Any prior protease inhibitors.
• Rifampin or rifabutin within 14 days prior to study entry.
• Excluded within 30 days prior to study entry:

Where it is running

• Children's Hosp of Los Angeles — Los Angeles, California, United States
• Univ of Southern California / LA County USC Med Ctr — Los Angeles, California, United States
• UCLA CARE Ctr — Los Angeles, California, United States
• Univ of California / San Diego Treatment Ctr — San Diego, California, United States
• San Francisco AIDS Clinic / San Francisco Gen Hosp — San Francisco, California, United States
• San Francisco Gen Hosp — San Francisco, California, United States
• Stanford at Kaiser / Kaiser Permanente Med Ctr — San Francisco, California, United States
• San Mateo AIDS Program / Stanford Univ — Stanford, California, United States
• Stanford Univ Med Ctr — Stanford, California, United States
• Harbor UCLA Med Ctr — Torrance, California, United States
• Kaiser Permanente Franklin Med Ctr — Denver, Colorado, United States
• Mountain States Reg Hemo Ctr / Univ of Colorado — Denver, Colorado, United States
• Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
• George Washington Univ / Hershey Med Ctr — Washington D.C., District of Columbia, United States
• Georgetown Univ Hosp — Washington D.C., District of Columbia, United States
• Howard Univ — Washington D.C., District of Columbia, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Univ of Miami (Pediatric) — Miami, Florida, United States
• Emory Univ — Atlanta, Georgia, United States
• Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr — Atlanta, Georgia, United States
• Queens Med Ctr — Honolulu, Hawaii, United States
• Univ of Hawaii — Honolulu, Hawaii, United States
• Northwestern Univ Med School — Chicago, Illinois, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Univ of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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