Last updated: 11/07/2018 16:33:09
A Phase II, Randomized, Open-Label Comparative, Pilot Study of Two Different Dosage Regimens of Amprenavir (600 mg BID vs. 900 mg BID) in Combination with Ritonavir (100 mg BID) Plus Abacavir, Another NRTI, and Either Efavirenz or Tenofovir DF in HIV-1 Infected Subjects with Virologic Evidence o ...
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Phase II, Randomized, Open-Label Comparative, Pilot Study of Two Different Dosage Regimens of Amprenavir (600 mg BID vs. 900 mg BID) in Combination with Ritonavir (100 mg BID) Plus Abacavir, Another NRTI, and Either Efavirenz or Tenofovir DF in HIV-1 Infected Subjects with Virologic Evidence o ...
Trial description: A Phase II, Randomized, Open-Label Comparative, Pilot Study of Two Different Dosage Regimens of Amprenavir (600 mg BID vs. 900 mg BID) in Combination with Ritonavir (100 mg BID) Plus Abacavir, Another NRTI, and Either Efavirenz or Tenofovir DF in HIV-1 Infected Subjects with Virologic Evidence o ...
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Haubrich, R., Hernandez, J., Bates, M., Thompson, M., Margolis, D., Pappa, K., Yau, L., Schooley, R., “Determinants of Replication Capacity (RC) in HIV-1 Isolates from ART-experienced Adults Failing a PI-Based Regimen”, oral presentation 1294, XV International AIDS Conference, July 11 to 16, 2004, Bangkok, Thailand.
Haubrich, R., Hernandez, J., Bates, M., Thompson, M., Margolis, D., Pappa, K., Yau, L., Schooley, R., “Determinants of Replication Capacity (RC) in HIV-1 Isolates from ART-experienced Adults Failing a PI-Based Regimen”, poster number 146, XIII International HIV Drug Resistance Workshop, June 8 to 12, 2004, Tenerife Sur-Costa Adeje, Canary Islands, Spain.
Haubrich, R., Thompson, M., Margolis, D., Schneider, S., Schooley, R., Richman, D., Pappa, K., Yau, L., Hessenthaler, S., and Hernandez, J., Virologic Response to Amprenavir (APV)/Ritonavir (RTV)-based Regimens in NNRTI-Naive or Experienced Adults Selected by Baseline Susceptibility (ESS40006): 24-wk Data", poster number P4, the 2nd International Workshop on Management of Treatment-Experienced Patients, September 25 to 27, 2002, San Diego, California."
Schooley, R., Haubrich, R., Sension, M., Taege, A., Becker, S., Richman, D., Wire, MB, Yau, L., Lou, Y., Pappa, K., Pierce, A. (2001), “Efficacy, Safety and Amprenavir (APV) Pharmacokinetic (PK) Responses of Twice-daily APV and Ritonavir (RTV) Regimens in HIV-1 Infected Treatment-experienced Adults for 48 Weeks (ESS40006)”, poster number 1924, the 41st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), December 16 to 19, 2001, Chicago, Illinois.
Schooley, R., Haubrich, R., Thompson, M., Margolis, D., Schneider, S., Richman, D., Pappa, K., Yau, L., Hessenthaler, S., Hernandez, J., “Effect of Amprenavir Hypersusceptibility on the Response to APV/Ritonavir-based Therapy in ART experienced Adults Selected by Baseline Susceptibility (ESS40006): 24-week Data”, oral presentation 143, 10th Conference on Retroviruses and Opportunistic Infections, February 10 to 14, 2003, Boston, Massachusetts.
Schooley, R., Sension, M., Taege, A., Haubrich, R., Becker, S., Richman, D., Thompson, M., McClernon, D., Wire, M., Lou, Y., Yau, L., Hessenthaler, S., Hernandez, J., Pappa, K., “Efficacy and Safety of Amprenavir (APV) and Ritonavir (RTV) Regimens in HIV-1 Infected Treatment Experienced Adults: 48-wk data”, poster number 045, Frontiers in Drug Development for Antiretroviral Therapies: HIV DART 2002, December 15 to 19, 2002, Naples, Florida.
Thompson, M., Tashima, K., Schooley, R., Haubrich, R., Yau, L., Hessenthaler, S., Hernandez, J., and Pappa, K., Different Impact on Metabolic Parameters of Amprenavir (APV)/Ritonavir (RTV) Regimens with Tenofovir (TDF) versus Efavirenz (EFV)", poster number 45, the 4th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV, September 22 to 25, 2002, San Diego, California."
Medical condition
Infection, Human Immunodeficiency Virus I
Product
amprenavir
Collaborators
Not applicable
Study date(s)
July 2000 to July 2002
Type
Not applicable
Phase
2
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2002-10-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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