Five-Drug Anti-HIV Treatment Followed by Treatment Interruption in Patients Who Have Recently Been Infected With HIV
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00000940 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: January 7, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Ritonavir Drug: Abacavir sulfate Drug: Amprenavir Drug: Lamivudine Drug: Stavudine | Phase 2 |
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 This study evaluates if viral suppression can be sustained after study therapy is withdrawn.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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 121 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | May 1999 |
Actual Study Completion Date : | October 2006 |


Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000940
United States, California | |
USC CRS | |
Los Angeles, California, United States, 90033 | |
UCLA CARE Center CRS | |
Los Angeles, California, United States, 90035 | |
Ucsd, Avrc Crs | |
San Diego, California, United States, 92103 | |
Ucsf Aids Crs | |
San Francisco, California, United States, 94110 | |
United States, Colorado | |
University of Colorado Hospital CRS | |
Aurora, Colorado, United States, 80045 | |
United States, Hawaii | |
Univ. of Hawaii at Manoa, Leahi Hosp. | |
Honolulu, Hawaii, United States, 96816 | |
United States, Massachusetts | |
Massachusetts General Hospital ACTG CRS | |
Boston, Massachusetts, United States, 02114 | |
SSTAR, Family Healthcare Ctr. | |
Fall River, Massachusetts, United States, 02720 | |
United States, Missouri | |
Washington U CRS | |
St. Louis, Missouri, United States, 63110 | |
United States, New York | |
Beth Israel Med. Ctr. ACTU | |
New York, New York, United States, 10003 | |
NY Univ. HIV/AIDS CRS | |
New York, New York, United States, 10016 | |
Columbia P&S CRS | |
New York, New York, United States, 10032 | |
AIDS Care CRS | |
Rochester, New York, United States, 14607 | |
McCree McCuller Wellness Ctr. at the Connection, Infectious Disease Unit | |
Rochester, New York, United States, 14642 | |
Univ. of Rochester ACTG CRS | |
Rochester, New York, United States, 14642 | |
United States, North Carolina | |
Unc Aids Crs | |
Chapel Hill, North Carolina, United States, 27514 | |
United States, Pennsylvania | |
Hosp. of the Univ. of Pennsylvania CRS | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Rhode Island | |
The Miriam Hosp. ACTG CRS | |
Providence, Rhode Island, United States, 02906 |
Study Chair: | Paul Volberding, MD | San Francisco Veterans Medical Center | |
Study Chair: | Elizabeth Connick, MD | Infectious Disease Division, University of Colorado Health Sciences Center |
Publications of Results:
Other Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000940 History of Changes |
Other Study ID Numbers: |
ACTG 371 10099 ( Registry Identifier: DAIDS ES ) ACTG 710 (substudy) ACTG 711 (substudy) ACTG 729 (substudy) ACTG 709 (substudy) AACTG 371 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | January 7, 2016 |
Last Verified: | January 2016 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Drug Therapy, Combination Stavudine Amprenavir/Ritonavir Protease Inhibitors Lamivudine VX 478 |
Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load Abacavir Sulfate Acute Infection Treatment Interruption |
Additional relevant MeSH terms:
Infection HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Ritonavir Amprenavir Lamivudine |
Abacavir Stavudine Dideoxynucleosides HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |