A Study of Three Treatment Combinations Using Zidovudine Plus Lamivudine Plus Indinavir in HIV-Infected Patients

Completed · Phase 2

Conditions studied: HIV Infections

In brief

To compare the proportion of patients who sustain suppression of plasma HIV RNA to undetectable levels \[AS PER AMENDMENT 09/19/97: below 200 copies/mL by Roche UltraSensitive assay\] among the 3 regimens during the maintenance phase. The objective of antiretroviral therapy is to reduce HIV replication, preserve immunologic function and delay the development of HIV-related complications. In patients administered potent antiretroviral regimens, HIV RNA levels are reduced below 500 copies/ml of plasma and below the level of detection of commercially available assays. This protocol attempts to learn if a less intensive regimen can successfully sustain viral suppression after induction with a triple-drug regimen. The study also addresses whether HIV can be eradicated in patients following prolonged treatment with induction and maintenance regimens.

Key facts

Study ID

NCT00001084

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

500

Expected to finish

1997-12-01

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…

• Patients must have:
• Documented HIV infection.
• A CD4 cell count >= 200 cells/mm3 within 90 days prior to study entry.
• Plasma HIV RNA >= 1000 copies/ml within 90 days prior to study entry.

You may not qualify if…

• Co-existing Condition:
• Patients with any of the following conditions or symptoms are excluded:
• A malignancy that requires systemic chemotherapy.
• Concurrent Medication:
• Excluded:
• Oral ketoconazole (Nizoral), terfenadine (Seldane), astemizole (Hismanal), cisapride (Propulsid), triazolam (Halcion) or midazolam (Versed).
• All antiretroviral therapies other than study medications.
• Rifabutin and rifampin.
• Investigational drugs and vaccines.
• Systemic cytotoxic chemotherapy.
• Interferon, interleukins, GM-CSF and HIV vaccines.
• Patients with any of the following prior conditions are excluded:
• Unexplained temperature > 38.5 degrees C for any 7 days within 30 days prior to study entry.
• Chronic diarrhea as defined as > 3 liquid stools per day persisting for 15 days within 30 days prior to study entry.
• Proven or suspected acute hepatitis within 30 days prior to study entry, even if AST and ALT are <= 5.0 X ULN (upper limit of normal).
• A history of >= Grade 2 bilateral peripheral neuropathy within 60 days prior to study entry.
• A history of intolerance to 300 mg/day of ZDV defined as any toxicity requiring a dose reduction or termination of ZDV.
• Prior Medication:
• Excluded:
• Acute therapy for an infection or other medical illness within 14 days prior to study entry.
• Any prior therapy with 3TC or experimental drug 1592.
• More than 2 weeks of lifetime exposure to protease inhibitor therapy; any exposure within 14 days prior to study entry.
• Interferons, interleukins, GM-CSF or HIV vaccines within 30 days prior to study entry.
• Any experimental therapy (drugs or vaccines) within 30 days prior to study entry.
• Rifampin or rifabutin within 14 days prior to study entry.

Where it is running

• Univ of Southern California / LA County USC Med Ctr — Los Angeles, California, United States
• Univ of California / San Diego Treatment Ctr — San Diego, California, United States
• San Francisco Gen Hosp — San Francisco, California, United States
• Stanford at Kaiser / Kaiser Permanente Med Ctr — San Francisco, California, United States
• Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium — San Jose, 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
• Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Emory Univ — 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
• Cook County Hosp — Chicago, Illinois, United States
• Indiana Univ Hosp — Indianapolis, Indiana, United States
• Division of Inf Diseases/ Indiana Univ Hosp — Indianapolis, Indiana, United States
• Univ of Iowa Hosp and Clinic — Iowa City, Iowa, United States
• Tulane Med Ctr Hosp — New Orleans, Louisiana, United States
• Tulane Univ School of Medicine — New Orleans, Louisiana, United States
• State of MD Div of Corrections / Johns Hopkins Univ Hosp — Baltimore, Maryland, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States
• Harvard (Massachusetts Gen Hosp) — Boston, Massachusetts, United States
• Beth Israel Deaconess - West Campus — Boston, Massachusetts, United States
• Hennepin County Med Clinic — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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