A Study of Indinavir Sulfate Given Together With Stavudine to HIV-Positive Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to see if it is safe and effective to give indinavir sulfate plus stavudine to HIV-infected patients who have already been treated with zidovudine.

Detailed Description

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Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Indinavir sulfate

Intervention Type DRUG

Stavudine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Concurrent Medication:

Allowed:

* Prophylaxis with aerosolized pentamidine, topical antifungals, TMP / SMX, dapsone, or isoniazid.

Patients must have:

* HIV infection.
* CD4 count 50 - 500 cells/mm3.
* Prior AZT use for more than 6 months OR documented intolerance to AZT with more than 6 months use of another anti-HIV therapy other than d4T or any protease inhibitor.
* No active opportunistic infection or visceral Kaposi's sarcoma.

NOTE:

* Patients with hemophilia may be enrolled at discretion of investigator.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Symptomatic neuropathy.
* Acute hepatitis.

Concurrent Medication:

Excluded:

* Antiretrovirals other than specified in protocol.
* Chronic therapy for an active opportunistic infection.
* Immunosuppressive therapy.

Prior Medication:

Excluded:

* Any prior protease inhibitor or d4T.
* Any nucleoside analogs within 2 weeks prior to study entry.
* Investigational agents or immunomodulators within 30 days prior to study entry.

Required:

* More than 6 months of prior AZT unless intolerant, in which case more than 6 months of another anti-HIV therapy (other than protease inhibitors or d4T).

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Merck & Co Inc

Whitehouse Station, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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37

Identifier Type: -

Identifier Source: secondary_id

246D