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NCT00000940 Clinical Trial

Five-Drug Anti-HIV Treatment Followed by Treatment Interruption in Patients Who Have Recently Been Infected With HIV

HIV Infections Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000940
Other study ID # ACTG 371
Secondary ID 10099ACTG 710 (s
Status Completed
Phase Phase 2
First received
Last updated
Start date May 1999
Est. completion date October 2006

Study information
Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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 This study evaluates if viral suppression can be sustained after study therapy is withdrawn.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.

Recruitment information / eligibility
Status Completed
Enrollment 121
Est. completion date October 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - Acute HIV infection (recently infected with HIV or recent seroconversion) - Karnofsky status of 80 or greater within 14 days prior to study entry - Acceptable methods of contraception - Able and willing to give written informed consent Exclusion Criteria: - Previously received anti-HIV drugs - Hepatitis within 30 days prior to study entry - Pancreatitis within 120 days prior to study entry - Radiation or chemotherapy within 30 days prior to study entry - Certain medications within 14 days prior to study entry - Experimental or investigational therapy within 30 days prior to study entry - Illness (non-HIV infection, cancer, etc.) at the time of study entry - Pregnant or breastfeeding

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ritonavir

• Abacavir sulfate

• Amprenavir

• Lamivudine

• Stavudine

Locations
Country Name City State
United States University of Colorado Hospital CRS Aurora Colorado
United States Massachusetts General Hospital ACTG CRS Boston Massachusetts
United States Unc Aids Crs Chapel Hill North Carolina
United States SSTAR, Family Healthcare Ctr. Fall River Massachusetts
United States Univ. of Hawaii at Manoa, Leahi Hosp. Honolulu Hawaii
United States UCLA CARE Center CRS Los Angeles California
United States USC CRS Los Angeles California
United States Beth Israel Med. Ctr. ACTU New York New York
United States Columbia P&S CRS New York New York
United States NY Univ. HIV/AIDS CRS New York New York
United States Hosp. of the Univ. of Pennsylvania CRS Philadelphia Pennsylvania
United States The Miriam Hosp. ACTG CRS Providence Rhode Island
United States AIDS Care CRS Rochester New York
United States McCree McCuller Wellness Ctr. at the Connection, Infectious Disease Unit Rochester New York
United States Univ. of Rochester ACTG CRS Rochester New York
United States Washington U CRS Saint Louis Missouri
United States Ucsd, Avrc Crs San Diego California
United States Ucsf Aids Crs San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (7)

Ait-Khaled M, Rakik A, Griffin P, Cutrell A, Fischl MA, Clumeck N, Greenberg SB, Rubio R, Peters BS, Pulido F, Gould J, Pearce G, Spreen W, Tisdale M, Lafon S; CNA3003 International Study Team. Mutations in HIV-1 reverse transcriptase during therapy with abacavir, lamivudine and zidovudine in HIV-1-infected adults with no prior antiretroviral therapy. Antivir Ther. 2002 Mar;7(1):43-51. — View Citation

Connick E, Bosch RJ, Aga E, Schlichtemeier R, Demeter LM, Volberding P; ACTG 709 Team. Augmented HIV-specific interferon-gamma responses, but impaired lymphoproliferation during interruption of antiretroviral treatment initiated in primary HIV infection. — View Citation

García F, Plana M, Mestre G, Arnedo M, Gil C, Miró JM, Cruceta A, Pumarola T, Gallart T, Gatell JM. Immunological and virological factors at baseline may predict response to structured therapy interruption in early stage chronic HIV-1 infection. AIDS. 2002 Sep 6;16(13):1761-5. — View Citation

García F, Plana M, Ortiz GM, Bonhoeffer S, Soriano A, Vidal C, Cruceta A, Arnedo M, Gil C, Pantaleo G, Pumarola T, Gallart T, Nixon DF, Miró JM, Gatell JM. The virological and immunological consequences of structured treatment interruptions in chronic HIV-1 infection. AIDS. 2001 Jun 15;15(9):F29-40. — View Citation

Mira JA, Macías J, Nogales C, Fernández-Rivera J, García-García JA, Ramos A, Pineda JA. Transient rebounds of low-level viraemia among HIV-infected patients under HAART are not associated with virological or immunological failure. Antivir Ther. 2002 Dec;7(4):251-6. — View Citation

Tilling R, Kinloch S, Goh LE, Cooper D, Perrin L, Lampe F, Zaunders J, Hoen B, Tsoukas C, Andersson J, Janossy G; Quest Study Group. Parallel decline of CD8+/CD38++ T cells and viraemia in response to quadruple highly active antiretroviral therapy in primary HIV infection. AIDS. 2002 Mar 8;16(4):589-96. — View Citation

Volberding P, Demeter L, Bosch RJ, Aga E, Pettinelli C, Hirsch M, Vogler M, Martinez A, Little S, Connick E; ACTG 371 Team. Antiretroviral therapy in acute and recent HIV infection: a prospective multicenter stratified trial of intentionally interrupted t — View Citation

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