Trials / Completed
CompletedNCT00085943
KALETRA Or LEXIVA With Ritonavir Combined With EPIVIR And Abacavir In Naive Subjects Over 48 Weeks
See Detailed Description
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 866 (planned)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This study will compare the ability of fosamprenavir 700 mg with ritonavir 100 mg twice a day or lopinavir 400 mg with ritonavir 100 mg twice a day both combined with a fixed dose combination tablet of abacavir 600 mg and lamivudine 300 mg once a day to suppress virus levels of HIV to less than 400 copies/mL of blood. In addition we will study the safety and tolerability of these compounds over the 48 week study period in patients naive to anti-HIV therapy.
Detailed description
A Phase IIIB, Randomized, Open-Label, Multicenter Study of the Safety and Efficacy of GW433908 (700mg BID) plus ritonavir (100mg BID) Versus Lopinavir/ritonavir (400mg/100mg BID) when Administered in Combination with the Abacavir/Lamivudine (600mg/300mg) Fixed-Dose Combination Tablet QD in Antiretroviral-Naive HIV-1 Infected Adults Over 48 Weeks
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LEXIVA (GW433908) | |
| DRUG | Ritonavir | |
| DRUG | KALETRA | |
| DRUG | EPIVIR | |
| DRUG | Ziagen | |
| DRUG | Abacavir/Lamivudine | |
| DRUG | Fosamprenavir |
Timeline
- Start date
- 2004-05-01
- First posted
- 2004-06-21
- Last updated
- 2011-05-16
Locations
119 sites across 14 countries: United States, Austria, Belgium, Canada, France, Germany, Italy, Latvia, Luxembourg, Poland, Portugal, Romania, Spain, Switzerland
Source: ClinicalTrials.gov record NCT00085943. Inclusion in this directory is not an endorsement.