Completed

Phase 2
Age: 16Years +
All Genders
ID00000940

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

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-29

121

Participants Needed

18

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

Trial Site Locations

Total: 18 locations

1

USC CRS

Los Angeles, California, United States, 90033

Status Unknown

2

UCLA CARE Center CRS

Los Angeles, California, United States, 90035

Status Unknown

3

Ucsd, Avrc Crs

San Diego, California, United States, 92103

Status Unknown

4

Ucsf Aids Crs

San Francisco, California, United States, 94110

Status Unknown

5

University of Colorado Hospital CRS

Aurora, Colorado, United States, 80045

Status Unknown

6

Univ. of Hawaii at Manoa, Leahi Hosp.

Honolulu, Hawaii, United States, 96816

Status Unknown

7

Massachusetts General Hospital ACTG CRS

Boston, Massachusetts, United States, 02114

Status Unknown

8

SSTAR, Family Healthcare Ctr.

Fall River, Massachusetts, United States, 02720

Status Unknown

9

Washington U CRS

St Louis, Missouri, United States, 63110

Status Unknown

10

Beth Israel Med. Ctr. ACTU

New York, New York, United States, 10003

Status Unknown

11

NY Univ. HIV/AIDS CRS

New York, New York, United States, 10016

Status Unknown

12

Columbia P&S CRS

New York, New York, United States, 10032

Status Unknown

13

AIDS Care CRS

Rochester, New York, United States, 14607

Status Unknown

14

McCree McCuller Wellness Ctr. at the Connection, Infectious Disease Unit

Rochester, New York, United States, 14642

Status Unknown

15

Univ. of Rochester ACTG CRS

Rochester, New York, United States, 14642

Status Unknown

16

Unc Aids Crs

Chapel Hill, North Carolina, United States, 27514

Status Unknown

17

Hosp. of the Univ. of Pennsylvania CRS

Philadelphia, Pennsylvania, United States, 19104

Status Unknown

18

The Miriam Hosp. ACTG CRS

Providence, Rhode Island, United States, 02906

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

0

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Published Research Related To This Trial

Mutations in HIV-1 reverse transcriptase during therapy with abacavir, lamivudine and zidovudine in HIV-1-infected adults with no prior antiretroviral therapy.

Mounir Ait-Khaled, Abdelrahim Rakik, Philip Griffin...

https://pubmed.ncbi.nlm.nih.gov/12008787

Immunological and virological factors at baseline may predict response to structured therapy interruption in early stage chronic HIV-1 infection.

Felipe García, Montserrat Plana, Gabriel Mestre...

https://pubmed.ncbi.nlm.nih.gov/12218387

Transient rebounds of low-level viraemia among HIV-infected patients under HAART are not associated with virological or immunological failure.

José A Mira, Juan Macías, Carmen Nogales...

https://pubmed.ncbi.nlm.nih.gov/12553479

Parallel decline of CD8+/CD38++ T cells and viraemia in response to quadruple highly active antiretroviral therapy in primary HIV infection.

Richard Tilling, Sabine Kinloch, Li-Ean Goh...

https://pubmed.ncbi.nlm.nih.gov/11873002

Antiretroviral therapy in acute and recent HIV infection: a prospective multicenter stratified trial of intentionally interrupted treatment.

Paul Volberding, Lisa Demeter, Ronald J Bosch...

https://pubmed.ncbi.nlm.nih.gov/19696651

Augmented HIV-specific interferon-gamma responses, but impaired lymphoproliferation during interruption of antiretroviral treatment initiated in primary HIV infection.

Elizabeth Connick, Ronald J Bosch, Evgenia Aga...

https://pubmed.ncbi.nlm.nih.gov/21637110