The Safety and Effectiveness of Didanosine Plus Stavudine Plus Delavirdine Mesylate Plus MKC-442 in HIV-Infected Patients Who Have Not Had Success With Protease Inhibitors
Stopped early · Phase 2
Conditions studied: HIV Infections
In brief
The purpose of this study is to see if it is safe and effective to give MKC-442, didanosine (ddI), stavudine (d4T), and delavirdine (DLV) to HIV-positive patients.
Key facts
- Study ID
- NCT00002420
- Run by
- Bristol-Myers Squibb
- People needed
- 25
- Last updated by the study team
- 2008-08-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- You may be eligible for this study if you:
- Are HIV-positive.
- Are at least 18 years old.
- Have experienced treatment failure on a previous anti-HIV drug combination that contained at least one protease inhibitor. Your viral load must be between 5,000 and 50,000 copies/ml after 6 months of continuous treatment with that drug combination.
- Agree to use a barrier method of birth control, such as condoms, during the study.
You may not qualify if…
- You will not be eligible for this study if you:
- Have a history of certain medical conditions, such as pancreatitis, peripheral neuropathy, seizure disorder, or AIDS-related cancer (except for Kaposi's sarcoma).
- Are allergic to any of the study drugs.
- Have ever taken certain anti-HIV medications including non-nucleoside reverse transcriptase inhibitors (NNRTIs), ddI, or d4T.
- Have taken certain other medications including interleukin-2, interferon or a vaccine within 30 days of study entry.
- Have received radiation therapy or chemotherapy within 30 days of study entry. (Local radiation therapy is allowed.)
- Abuse alcohol or drugs.
- Are pregnant or breast-feeding.
Where it is running
- Pacific Oaks Med Group — Beverly Hills, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.