Five-Drug Anti-HIV Treatment Followed by Treatment Interruption in Patients Who Have Recently Been Infected With HIV
|First Received Date ICMJE||November 2, 1999|
|Last Updated Date||May 17, 2012|
|Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00000940 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Five-Drug Anti-HIV Treatment Followed by Treatment Interruption in Patients Who Have Recently Been Infected With HIV|
|Official Title ICMJE||A Phase II Trial to Evaluate the Safety and Efficacy of Induction Treatment With Lamivudine Plus Stavudine Plus Abacavir Plus Amprenavir/Ritonavir Followed by Supervised Treatment Interruption in Subjects With Acute HIV Infection or Recent Seroconversion|
This study will determine what effect taking a combination of five anti-HIV drugs during the early stage of HIV infection, then temporarily stopping them once or twice, may have on the amount of HIV virus in the blood (viral load). The study will also evaluate the safety and effectiveness of this anti-HIV drug combination.
Acute, primary HIV infection represents a potentially unique opportunity to eradicate the infection. Although plasma viral load rises rapidly, the dominant infecting virus is relatively uniform genetically, and infection may not be fully established in all tissue sites until some time after exposure. Current antiretroviral therapy is able to reduce plasma viral load to unmeasurable levels in established infection. However, there are many questions that remain about the treatment of primary HIV infection. While it is assumed that aggressive antiretroviral regimens are required, it is not known how long they must be continued. It is hoped that after an interval of aggressive therapy, the number of agents could be safely reduced. This study evaluates if viral suppression can be sustained after study therapy is withdrawn.
Participants in this study will receive lamivudine (3TC), stavudine (d4T), abacavir (ABC), amprenavir (APV), and ritonavir (RTV) for at least 52 weeks. During this induction phase, participants will be followed through regular study visits every 4 or 8 weeks. If the participant's viral load and CD4 counts are within study parameters at the end of 52 weeks, the participant will discontinue all antiretroviral medications simultaneously. Participants in the treatment interruption phase will be followed weekly initially, every 2 weeks for 8 weeks, and then every 4 or 8 weeks. Treatment may be restarted if necessary during this phase based on viral load and CD4 counts. If treatment is restarted, the participant will receive 3TC, d4T, APV, and RTV but not ABC. During this reinduction phase, participants will be followed every 4 or 8 weeks.
Depending on viral load and CD4 counts, participants may be eligible for a second treatment interruption phase following the reinduction phase. Participants will once again stop all antiretroviral medications simultaneously and will have the same monitoring as in the first treatment interruption phase. Following this second treatment interruption, participants will be restarted on 3TC, d4T, APV, and RTV and will be evaluated at Weeks 4, 8, 16, and 24, at which time participants go off study.
The length of study participation for individual participants will vary. The length of each phase will be highly dependent on the participant's laboratory parameters. In general, participants will be enrolled in the study for 3 to 4 years. Participants may also enroll in immunology, compartment, pharmacology, and medication compliance substudies.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||HIV Infections|
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||October 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||16 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00000940|
|Other Study ID Numbers ICMJE||ACTG 371, 10099, ACTG 710 (substudy), ACTG 711 (substudy), ACTG 729 (substudy), ACTG 709 (substudy), AACTG 371|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||National Institute of Allergy and Infectious Diseases (NIAID)|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institute of Allergy and Infectious Diseases (NIAID)|
|Verification Date||May 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP