A Study of Indinavir Sulfate Given Together With Stavudine to HIV-Positive Patients
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: January 1996
History of Changes
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.
Drug : Indinavir sulfate
Drug : Stavudine
Primary Purpose: Treatment
|Official Title:||One Year Study in HIV-1 Seropositive, AZT-Experienced Patients to Evaluate the Safety and Efficacy of MK-639 Administered Concomitantly With Stavudine (d4T)|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
|Ages Eligible for Study:||18 Years to 60 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Prophylaxis with aerosolized pentamidine, topical antifungals, TMP / SMX, dapsone, or isoniazid.
- 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.
- Patients with hemophilia may be enrolled at discretion of investigator.
- Symptomatic neuropathy.
- Acute hepatitis.
- Antiretrovirals other than specified in protocol.
- Chronic therapy for an active opportunistic infection.
- Immunosuppressive therapy.
- 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.
- More than 6 months of prior AZT unless intolerant, in which case more than 6 months of
Patients must have:
Patients with the following symptoms or conditions are excluded:
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002354
Locations Show More
|United States, New Jersey|
|Merck & Co Inc|
|Whitehouse Station, New Jersey, United States, 088890100|
Sponsors and CollaboratorsMerck Sharp & Dohme Corp.
|Responsible Party:||Merck Sharp & Dohme Corp.|
|ClinicalTrials.gov Identifier:||NCT00002354 History of Changes|
|Other Study ID Numbers:||246D|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
HIV Protease Inhibitors
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on December 08, 2017
This information is provided by ClinicalTrials.gov.