Trials / Unknown
UnknownNCT00005017
Effectiveness and Safety of Epivir/Ziagen/Zerit (3TC/ABC/d4T) Versus Epivir/Ziagen/Sustiva (3TC/ABC/EFV) Versus Epivir/Ziagen/Agenerase/Norvir (3TC/ABC/APV/RTV) in HIV Patients Who Have Never Received Treatment
A Phase IV, Open-Label, Randomized Study to Compare the Efficacy and Safety of Epivir/Ziagen/Zerit (3TC/ABC/d4T) Versus Epivir/Ziagen/Sustiva (3TC/ABC/EFV) Versus Epivir/Ziagen/Agenerase/Norvir (3TC/ABC/APV/RTV) for 96 Weeks in the Treatment of HIV-1 Infected Subjects Who Are Antiretroviral Therapy Naive
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 300 (planned)
- Sponsor
- Glaxo Wellcome · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to see how effective and safe it is to give 1 of the 3 following treatments to patients who may not have received anti-HIV treatment: 1) lamivudine (3TC)/abacavir (ABC)/stavudine (d4T); 2) 3TC/ABC/efavirenz (EFV); or 3) 3TC/ABC/amprenavir (APV)/ritonavir (RTV).
Detailed description
Patients are randomized to initiate antiretroviral therapy in 1 of 3 treatment groups. Within each group they are stratified based on HIV-1 plasma RNA levels. Group 1: Patients receive 3TC/ABC/d4T; Group 2: Patients receive 3TC/ABC/EFV; and Group 3: Patients receive 3TC/ABC/APV/RTV. Treatment continues for 96 weeks. Blood samples are collected to measure plasma HIV RNA and CD4 counts and patients are assessed regularly. In the event of incomplete viral suppression or virologic failure, patients will be switched to secondary therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ritonavir | |
| DRUG | Abacavir sulfate | |
| DRUG | Amprenavir | |
| DRUG | Efavirenz | |
| DRUG | Lamivudine | |
| DRUG | Stavudine |
Timeline
- First posted
- 2001-08-31
- Last updated
- 2005-06-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00005017. Inclusion in this directory is not an endorsement.