A Six-Month Safety and Antiviral Study in HIV-1 Seropositive, AZT-Experienced Patients With CD4 Counts Less Than or Equal to 50 Cells/mm3 to Evaluate MK-639 Alone Versus Zidovudine (AZT) and 3TC Versus the Combination of MK-639 With AZT/3TC

Study Overview
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Brief Summary
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To compare effects on CD4 counts and serum viral RNA among HIV-seropositive, zidovudine (AZT)-experienced patients in three treatment arms: indinavir sulfate ( MK-639; Crixivan ) plus AZT plus lamivudine ( 3TC ) versus MK-639 alone versus AZT/3TC.

Detailed Description
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AZT-experienced patients are randomized to receive MK-639/AZT/3TC or MK-639 alone or AZT/3TC. Additionally, patients who have received < 6 months of AZT or who are intolerant but received prior 3TC or who require concomitant rifampin therapy may receive open-label MK-639.

Official Title
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A Six-Month Safety and Antiviral Study in HIV-1 Seropositive, AZT-Experienced Patients With CD4 Counts Less Than or Equal to 50 Cells/mm3 to Evaluate MK-639 Alone Versus Zidovudine (AZT) and 3TC Versus the Combination of MK-639 With AZT/3TC

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Indinavir sulfate
* Drug: Lamivudine
* Drug: Zidovudine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Concurrent Medication: Allowed for all patients: Standard prophylaxis for opportunistic infections. Continuation of treatment for opportunistic infection. Allowed for open-label study patients: Rifampin. Patients must have: HIV positivity. CD4 count <= 50 cells/mm3. More than 6 months of prior AZT (blinded study only). NOTE: Patients on the open-label study must have AZT intolerance or have < 6 months of prior AZT. Prior Medication: Required for blinded study patients: > 6 months of prior AZT. Required for open-label study patients: < 6 months of prior AZT. Allowed for open-label study patients: Prior 3TC. Exclusion Criteria Concurrent Medication: Excluded in all patients: Immunosuppressants. Excluded in blinded study patients: AZT, ddI, ddC, or d4T. Rifampin. Excluded in open-label study patients: 3TC. Prior Medication: Excluded in all patients: Prior protease inhibitors. Investigational agents and immunomodulators within 30 days prior to study entry. Immunosuppressants within 2 weeks prior to study entry. Excluded in blinded study patients: Any prior 3TC. AZT, ddI, ddC, or d4T within 2 weeks prior to study entry. Excluded in open-label study patients: 3TC within 30 days prior to study entry.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Indinavir sulfate|nan|
|Drug: Lamivudine|nan|
|Drug: Zidovudine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Antiviral Agents, Zidovudine, HIV Protease Inhibitors, Lamivudine, Indinavir