Four-Drug Combination Treatment in Hiv-Infected Subjects Failing Therapy With Antiretroviral Regimens
Status and phase
Completed
Phase 2
Conditions
HIV Infections
Treatments
Drug: 2 NRTIs
Drug: capravirine
Drug: Kaletra
Details and patient eligibility
About
This is a 48 week study for HIV-infected patients who have failed several regimens including PI's, NNRTs and NRTIs. Patients will be randomly selected to be in 1 of 4 groups. Three of the 4 groups will contain capravirine in different doses combined with Kaletra and nucleosides and one of the groups will be a combination of Kaletra and nucleosides without the capravirine.
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- HIV-infected male or female at least 18 years of age
- HIV RNA level >1000 copies/mL at screening
- Subject has failed regimens that included at least 1 protease inhibitor but not more than 3 protease inhibitors, at least 1 nonnucleoside reverse transcriptase inhibitor, and least 2 nucleoside reverse transcriptase inhibitors
- Adequate renal function
- Adequate hematological function
- Adequate liver function
Exclusion criteria
- Women who are pregnant or lactating
- No previous experience with Kaletra
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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