Last updated: 11/07/2018 18:10:59
A Phase III Trial to Evaluate the Safety and Antiviral Efficacy of 141W94 in Combination with RETROVIR and EPIVIR Compared to RETROVIR and EPIVIR Alone in Patients with HIV Infection.
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 III Trial to Evaluate the Safety and Antiviral Efficacy of 141W94 in Combination with RETROVIR and EPIVIR Compared to RETROVIR and EPIVIR Alone in Patients with HIV Infection.
Trial description: A Phase III Trial to Evaluate the Safety and Antiviral Efficacy of 141W94 in Combination with RETROVIR and EPIVIR Compared to RETROVIR and EPIVIR Alone in Patients with HIV Infection.
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:
Goodgame CJ et al. Amprenavir in combination with lamivudine and zidovudine versus lamivudine and zidovudine alone in HIV-1-infected antiretroviral-naive adults. Amprenavir PROAB3001 International Study Team. Antivir Ther 5:215-225, 2000.
Goodgame CJ, et al Amprenavir (141W94, APV USAN Approved)/3TC/ZDV is Superior to 3TC/ZDV in HIV?1 Infected Antiretroviral Naive Subjects. AIDS 12 (Suppl. 4): 36.1998.
Goodgame CJ, et al. Amprenavir (141W94, APV USAN approved)/3TC/ZDV is superior to 3TC/ZDV in HIV?1 infected antiretroviral therapy?naive subjects. 38th Interscience Conference on Antimicrobial Agents and Chemotherapy 24 Sep 1998. Abstract LB 29.
Goodgame CJ, et al. Amprenavir (141W94, APV)/3TC/ZDV Exerts Durable Antiviral Activity in HIV-1 Infected Antiretroviral Therapy-Naïve Subjects Through 48 Weeks of Therapy PROAB3001. 39th Interscience Conference on Antimicrobial Agents and Chemotherapy. San Francisco, CA, USA. 26-29 September, 1999. Abstract 472.
Pedneault L, et al. AMPRENAVIR: A NEW PROTEASE INHIBITOR WITH A FAVOURABLE METABOLIC PROFILE. 1st International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV. San Diego, CA, US. 26–28 June 1999. Abstract 34.
Pottage J et al. Amprenavir (APV,141W94)/3TC/ZDV exerts potent and durable antiviral activity over 48 weeks of therapy in HIV-1 infected antiretroviral therapy naïve subjects. 7th European Conference on Clinical Aspects and treatment of HIV-Infection. Lisbon, Portugal, 23-27 October 1999. Abstract 521
Medical condition
Infection, Human Immunodeficiency Virus
Product
amprenavir
Collaborators
Not applicable
Study date(s)
May 1997 to April 1999
Type
Not applicable
Phase
3
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
1999-21-04
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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