Status:
COMPLETED
A Study of Three Treatment Combinations Using Zidovudine Plus Lamivudine Plus Indinavir in HIV-Infected Patients
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 regi...
Detailed Description
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 antiretrovir...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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.
- Exclusion Criteria
- 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.
- Systemic cytotoxic chemotherapy within 30 days prior to study entry.
- Oral ketoconazole (Nizoral), terfenadine (Seldane), astemizole (Hismanal), cisapride (Propulsid), triazolam (Halcion) or midazolam (Versed).
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
December 1 1997
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00001084
End Date
December 1 1997
Last Update
November 4 2021
Active Locations (45)
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1
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
2
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
3
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
4
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, United States, 94115